Solid state forms of ULK inhibitors

Abstract

Provided herein, in part, are solid-state forms of the compound represented by Formula (I): (Formula (I)) or a solvate thereof, pharmaceutical compositions comprising the solid-state forms, processes of making the solid-state forms, and methods of using the solid-state forms.

Description

SOLID STATE FORMS OF ULK INHIBITORSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 703,333, filed October 4, 2024, which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present disclosure relates to solid-state forms of the compound represented by Formula (I), or a solvate thereof, their pharmaceutical compositions, processes for their preparation, and methods for their use.BACKGROUND

[0003] Autophagy is a process that enables cells to recycle cellular organelles, proteins, stored lipids, glucagon, and other materials for the purpose of generating nutrients under periods of stress. These cellular contents are recycled by engulfment in vesicles called autophagosomes. Autophagosomes subsequently merge with lysosomes that degrade the autophagosomal contents for recycling of nutrients to the cell. Tumor cells are prone to activate autophagy, as these cells have a high metabolic demand, experience cellular stress, and frequently are in hypoxic environments with limited blood flow and nutrient supply. Moreover, chemotherapy and targeted anti -cancer therapies have been shown to induce autophagy as a treatment resistance mechanism, and combination of autophagy inhibition (by genetic loss of function mutations in autophagy genes or by pharmacologic means) with chemotherapeutic regimens has been shown to suppress tumor growth and trigger tumor cell apoptosis to a greater extent than single agent chemotherapy alone.

[0004] Mutant Ras proteins drive approximately 30 percent of all human cancers - including 95 percent of pancreatic cancers, 45 percent of colorectal cancers, and 30% of lung cancers, and treatment of these mutant Ras cancers is currently an area of high unmet medical need. Mutant Ras cancers are highly proliferative and depend on basal levels of autophagy for survival, suggesting that inhibition of autophagy in these “autophagy addicted” cancers is a viable therapeutic approach.

[0005] Currently, the most widely used autophagy inhibitors are chloroquine and hydroxychloroquine, which are well-known anti-malarial agents. These anti-malarials have beenthought to block autophagy by being sequestered in the lysosomal compartment, raising the pH of these lysosomes and thereby inactivating proteases that degrade and recycle nutrients. These anti-malarial agents have multiple mechanisms of action beyond inhibiting lysosomes and are known to induce retinopathies in patients. Hence there is a need for more targeted agents which selectively block autophagy and do not exhibit the toxicities of these anti-malarial agents. Unc- 51-like autophagy-activating kinase 1 (ULK1) kinase is the initiating protein of autophagy and is a serine / threonine kinase. The ULK1 kinase complex is activated in response to cellular stress including nutrient deprivation and energy depletion. Nutrient deprivation activates ULK kinase activity through inhibition of mTORCl, and energy depletion activates ULK kinase activity through activation by AMP-activated protein kinase AMPK. Importantly, kinase dead mutants of ULK kinase block initiation of canonical autophagy, suggesting that small molecule inhibitors of ULK kinase activity would be able to block autophagy.

[0006] Further mechanistic studies have shown that genetic deletion of ULK 1 inhibits autophagy in cancer cells, relieving FOX3A turn-over and upregulation of the pro-apoptotic protein PUMA. In addition to classical activation of canonical autophagy, ULK1 kinase activity has been shown to be required for Bcl-2-L-13 mediated mitophagy (autophagy of damaged mitochondria). ULK1 and ULK2 kinases have also been demonstrated to rewire cancer cell glucose metabolism which favors increases in the reducing agent NADPH leading to a reduction in toxic reactive oxygen species (ROS). ULK inhibitors may also find utility in blocking these noncanonical pro-tumoral activities of ULK.

[0007] Autophagy is also upregulated in host cells and tissues in cancer. Autophagy in pancreatic tissue stellate cells was demonstrated to support tumor growth. Pancreatic stellate cells were shown to support pancreatic cancer tumor metabolism through autophagic alanine secretion. Inhibition of host tissue autophagy was demonstrated to lead to a depletion in circulating arginine (a required amino acid for tumor metabolism and growth) through liver - mediated increases in arginase secretion. Activation of ULK 1 kinase was also shown to inactivate the STING pathway in immune cells through inhibitory phosphorylation of STING, mediating a negative feedback mechanism for limiting an innate immune cell response mediated by interferons. Thus, not only is autophagy activated in tumor cells (cancer cell autonomous), but also in other cells in the tumor microenvironment or host tissues (cancer call nonautonomous) to support tumor survival and growth.

[0008] Mutant Ras cancers are addicted to autophagy. In pancreatic cancer, mutant Ras signals predominantly through the MAP kinase pathway. Mutant Ras activates RAF kinases, which in turn activate mitogen-activated protein kinase (MEK) kinases, which finally activate ERK kinases: mutant Ras -> RAF -> MEK -> ERK. Despite mutant Ras signaling through the MAP kinase pathway, inhibitors of this pathway have provided no or little clinical benefit in clinical trials when used as single agents. It has been recently reported that inhibition of the MAP kinase pathway induces autophagy as a compensatory adaptive stress response resistance mechanism. When MEK inhibitors were combined with the autophagy inhibitor hydroxychloroquine, there was synergistic activity leading to regression of a number of mutant Ras or mutant BRAE cancers. Similarly, when ERK inhibitors were combined with the autophagy inhibitor hydroxychloroquine or chloroquine, there was synergistic activity leading to inhibition of mutant Ras pancreatic cancers. It has been demonstrated that genetic depletion of RAF kinases (CRAF and BRAF) led to synergistic anti-tumor activity in mutant Ras cancer cell lines when autophagy was also genetically depleted. In composite, recent publications highlight that dual inhibition of the RAS / MAPK pathway and the autophagy pathway in mutant Ras cancers is a promising treatment regimen for patients with mutant Ras cancers. It has also been demonstrated that other targeted therapies and chemotherapeutic agents activate tumor autophagy as a resistance mechanism; hence there is rationale for combining such targeted therapeutics or chemotherapeutic agents with inhibitors of autophagy.

[0009] It has also been demonstrated that tumor driver receptor tyrosine kinases (RTKs) can modulate autophagy, and that inhibitors of RTKs also activate autophagy through the same mTORCl and AMP kinase pathways as do inhibitors of mutant RAS or RAF. Inhibitors of mutant oncogenic KIT kinase, inhibitors of oncogenic EGFR kinase, and inhibitors of oncogenic FLT3 kinase are known to activate autophagy as an adaptive stress response resistance mechanism.

[0010] There is a need for new targeted therapies which inhibit autophagy and can be used in combination with RTK / RAS / MAPK pathway inhibitors, chemotherapeutic agents, and / or other targeted therapeutics.

[0011] Different solid-state forms, including salts and solvated forms, of an active pharmaceutical ingredient may have different properties. Different solid-state forms, salts and solvates of an active pharmaceutical ingredient may give rise to a variety of other polymorphs orcrystalline forms, co-crystals, solvates and other solid-state forms with improved properties. Such improved properties, e.g., differences in physical, mechanical, chemical, or physicochemical properties, can provide solid-state forms with desirable properties which enable their clinical and commercial development. Improved beneficial properties in, but not limited to, stability, solubility, melting point, hardness, hygroscopicity, flowability, or compressibility, can result, for example, in improvement in bioavailability, dissolution profile, process reproducibility, ease of purification, ease of handling, ease of manufacturing, ease of processing, storage stability, or shelf-life. Improved properties of a solid-state form may also enable for better formulation optimization, leading to development and commercialization of superior drug products otherwise not available to patients. There is a need for new solid-state forms with improved properties for use in the pharmaceutical industry and leading to improved drugs available to patients.SUMMARY

[0012] Described herein, in part, are solid-state forms of the compound represented by Formula (I):or a solvate thereof, pharmaceutical compositions comprising the solid-state forms, processes of making the solid-state forms, and methods of using the solid-state forms.

[0013] Provided herein, in part, are methods of preparing solid-state forms of the compound represented by Formula (I), or a solvate thereof, and the use of these solid-state forms for the preparation of pharmaceutical compositions and / or pharmaceutical formulations of the compound represented by Formula (I), or a solvate thereof.

[0014] Provided herein, in part, are methods of treating diseases and conditions including, but not limited to, cancer, such as gastrointestinal stromal tumors, esophageal cancer, gastric cancer, melanomas, gliomas, glioblastomas, ovarian cancer, bladder cancer, pancreaticcancer, prostate cancer, lung cancers, breast cancers, renal cancers, hepatic cancers, osteosarcomas, Ewing sarcoma, multiple myelomas, cervical carcinomas, cancers that are metastatic to bone, papillary thyroid carcinoma, non-small cell lung cancer, colorectal cancer, acute myeloid leukemia, relapsed acute myeloid leukemia, refractory acute myeloid leukemia, myelodysplastic syndrome, acute lymphocytic leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia, myeloproliferative neoplasms, and mantle cell lymphoma.

[0015] In another embodiment, provided herein is a method of treating a tumor in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of a solid-state compound described herein or pharmaceutically acceptable solvates thereof, or of a pharmaceutical composition described herein.

[0016] In some embodiments, the methods further comprise administering to the patient one or more additional therapeutic agents.

[0017] Also provided herein, in part, are solid-state forms of the compound represented by Formula (I), or a solvate thereof, or a composition thereof, for use in therapy.

[0018] Provided herein, in part, are solid-state forms of the compound represented by Formula (I), or a solvate thereof, or a composition thereof, for use in treating diseases and conditions including, but not limited to, cancer, such as gastrointestinal stromal tumors, esophageal cancer, gastric cancer, melanomas, gliomas, glioblastomas, ovarian cancer, bladder cancer, pancreatic cancer, prostate cancer, lung cancers, breast cancers, renal cancers, hepatic cancers, osteosarcomas, Ewing sarcoma, multiple myelomas, cervical carcinomas, cancers that are metastatic to bone, papillary thyroid carcinoma, non-small cell lung cancer, colorectal cancer, acute myeloid leukemia, relapsed acute myeloid leukemia, refractory acute myeloid leukemia, myelodysplastic syndrome, acute lymphocytic leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia, myeloproliferative neoplasms, and mantle cell lymphoma.

[0019] In another embodiment, provided herein are solid-state compounds described herein or pharmaceutically acceptable solvates thereof, or of pharmaceutical compositions described herein for use in treating a tumor in a patient in need thereof.

[0020] In some embodiments, the compound or composition for use further comprises administering to the patient one or more additional therapeutic agents.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG. 1 shows an X-ray powder diffraction (“XRPD”) diffractogram of crystalline Form 1 of the compound represented by Formula (I).

[0022] FIG. 2 shows a thermogravimetric (“TG”) / differential scanning calorimetry (“DSC”) thermogram of crystalline Form 1 of the compound represented by Formula (I).

[0023] FIG. 3 shows a first heat cycle in the differential scanning calorimetry (“DSC”) thermogram of crystalline Form 1 of the compound represented by Formula (I).

[0024] FIG. 4 shows the cooling cycle in the DSC thermogram of crystalline Form 1 of the compound represented by Formula (I).

[0025] FIG. 5 shows the second heat cycle in the DSC thermogram of crystalline Form 1 of the compound represented by Formula (I).

[0026] FIG. 6 shows a dynamic vapor sorption (“DVS”) isotherm plot of crystalline Form 1 of the compound represented by Formula (I).

[0027] FIG. 7 shows a DVS kinetic plot of crystalline Form 1 of the compound represented by Formula (I).

[0028] FIG. 8 shows an XRPD diffractogram of pre-DVS (top) and post-DVS (bottom) of crystalline Form 1 of the compound represented by Formula (I).

[0029] FIG. 9 shows a Fourier-transform infrared spectroscopy (“FT-IR”) spectrum of crystalline Form 1 of the compound represented by Formula (I).

[0030] FIG. 10 shows aJH NMR spectrum of crystalline Form 1 of the compound represented by Formula (I).

[0031] FIG. 11 shows an XRPD diffractogram of crystalline Form 6 of the compound represented by Formula (I).

[0032] FIG. 12 shows XRPD diffractogram s of additional forms of the compound represented by Formula (I) obtained from a seven-day stability study of crystalline Form 1 of the compound represented by Formula (I).

[0033] FIG. 13 shows XRPD diffractogram s of additional forms of the compound represented by Formula (I) obtained from a seven-day stability study of crystalline Form 6 of the compound represented by Formula (I).

[0034] FIG. 14A shows an XRPD diffractogram of crystalline Form 1 of the compound represented by Formula (I) compared to the XRPD diffractogram of material post-lyophilization (FIG. 14B).

[0035] FIG. 15 shows XRPD diffractograms of additional forms of the compound represented by Formula (I) obtained from a solvent solubility screen.

[0036] FIG. 16 shows an XRPD diffractogram of crystalline Form 2 of the compound represented by Formula (I).

[0037] FIG. 17 shows an XRPD diffractogram of crystalline Form 3 of the compound represented by Formula (I).

[0038] FIG. 18 shows an XRPD diffractogram of crystalline Form 4 of the compound represented by Formula (I).

[0039] FIG. 19 shows an XRPD diffractogram of crystalline Form 5 of the compound represented by Formula (I).DETAILED DESCRIPTION

[0040] The features and other details of the disclosure will now be more particularly described. Certain terms employed in the specification, examples and appended claims are collected here. These definitions should be read in light of the remainder of the disclosure. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood.Definitions

[0041] Terms used in the singular will also include the plural. For example, “a” means one or more unless indicated otherwise.

[0042] All ranges recited herein include the endpoints, including those that recite a range “between” two values. The terms “substantially” and “about” are to be construed as modifying a term or value such that it is not an absolute. This includes, at very least, the degree of expected experimental variance, experimental error, technique variance, technique error and instrument variance, instrumental error for a given technique used to measure a value.

[0043] As used herein, “about” includes and describes the value or parameter per se. For example, “about x” includes and describes “x” per se. In some embodiments, the term “about” when used in association with a measurement, or used to modify a value, a unit, a constant, or a range of values, refers to variations of ± 10%. “About” in context of XRPD and DSC means ± 0.2° at 2-theta for XRPD peaks, ± 3 °C for DSC, respectively.

[0044] As used herein, the term “adding” does not limit the order, method or how the materials being added are combined, unless indicated otherwise. For instance, “adding X to Y”may also describe “adding Y to X.” Furthermore, “adding X and Y to Z” may also describe the various other combinations such as “adding X to Y and Z,” “adding X and Z to Y,” “adding Y to X and Z,” “adding Y and Z to X,” and “adding Z to X and Y ”

[0045] As used herein, the term “chemical purity” refers to a measurement of how free a compound is from impurities, which may include other crystalline forms of the compound.

[0046] As used herein, the term “by weight” regarding percentage chemical purity refers to the weight of the reference standard (Wstd) times the purity of the reference standard (Pstd), divided by the weight of the working sample (Wsmp), times 100.

[0047] As used herein, the terms “individual,” “patient,” or “subject” are used interchangeably and include any animal, including mammals, preferably mice, rats, other rodents, rabbits, dogs, cats, swine, cattle, sheep, horses, or primates, and most preferably humans. The compounds described herein can be administered to a mammal, such as a human, but can also be administered to other mammals such as an animal in need of veterinary treatment, e.g., domestic animals (e.g., dogs, cats, and the like), farm animals (e.g., cows, sheep, pigs, horses, and the like) and laboratory animals (e.g., rats, mice, guinea pigs, and the like).

[0048] As used herein, the term “excipient” refers to a substance that may be beneficial to include in a composition with an active agent. The term “excipient” includes inert substances as well as functional excipients that may result in beneficial properties of the composition. Exemplary excipients include but are not limited to polymers, glidants, sugars, lubricants, salts, buffers, fats, fillers, disintegrating agents, binders, surfactants, high surface area substrates, flavorants, carriers, matrix materials, diluents, and so forth.

[0049] As used herein, the terms “pharmaceutically acceptable” or “pharmacologically acceptable” includes molecular entities and compositions that do not produce an adverse, allergic or other untoward reaction when administered to an animal, or a human, as appropriate. For human administration, preparations should meet sterility, pyrogenicity, and general safety and purity standards as required by FDA standards.

[0050] As used herein, the term “pharmaceutically acceptable carrier” or “pharmaceutically acceptable excipient” as used herein refers to any and all solvents, dispersion media, coatings, isotonic and absorption delaying agents, and the like, that are compatible with pharmaceutical administration. The use of such media and agents for pharmaceutically activesubstances is well known in the art. The compositions may also contain other active compounds providing supplemental, additional, or enhanced therapeutic functions.

[0051] As used herein, the term “pharmaceutical composition” as used herein refers to a composition comprising at least one compound as disclosed herein formulated together with one or more pharmaceutically acceptable carriers, excipients or diluents.

[0052] As used herein, the term “therapeutically effective amount” means the amount of the subject compound that will elicit the biological or medical response of a tissue, system or animal, (e.g., mammal or human) that is being sought by the researcher, veterinarian, medical doctor or other clinician. A compound described herein, e.g., the solid-state form of the compound represented by Formula (I), or a solvate thereof, is administered in therapeutically effective amounts to treat a condition disclosed herein. Alternatively, a therapeutically effective amount of a compound is the quantity required to achieve a desired therapeutic and / or prophylactic effect, such as an amount which results in the prevention of or a decrease in the symptoms associated with the condition.

[0053] As used herein and unless otherwise indicated, the terms “treat,” “treating” and “treatment” refer to the alleviation of a disease or disorder and / or at least one of its attendant symptoms, and includes any effect, e.g., lessening, reducing, modulating, or eliminating, that results in the improvement of the condition, disease, disorder and the like.

[0054] As used herein and unless otherwise indicated, the terms “prevent,” “preventing” and “prevention” refer to the inhibition of a symptom of a disease or disorder or the disease itself.

[0055] As used herein, the term “active agent” means a drug, medicament, pharmaceutical, therapeutic agent, for example, the solid-state form of the compound represented by Formula (I), or a solvate thereof, as described herein.

[0056] As used herein, the term “oral formulation,” refers to a composition or medium used to administer a compound as disclosed herein (e.g., the solid-state form of the compound represented by Formula (I), or a solvate thereof) to a subject in need thereof by oral administration. Typically, an oral formulation is administered via the mouth, however, “oral formulation” as used herein is intended to cover any substance which is administered to a subject and is absorbed across a membrane, e.g., a mucosal membrane, of the gastrointestinal tract, including, e.g., the mouth, esophagus, stomach, small intestine, large intestine, and colon. In oneembodiment, the oral formulation is a solid oral formulation. In one embodiment, the oral formulation is a solid oral formulation administered to a subject in need thereof via the mouth.

[0057] As used herein, the terms “isolated,” “isolating” in reference to solid-state forms of the compound represented by Formula (I), or a solvate thereof, corresponds to a solid-state form of the compound represented by Formula (I), or a solvate thereof, that is physically separated from the reaction mixture or the slurry.

[0058] A reaction mixture may be characterized herein as being at or allowed to come to “room temperature” or “ambient temperature,” often abbreviated as “RT” or “rt.” This means that the temperature of the thing is close to, or the same as, that of the space, e.g., the room or fume hood, in which the thing is located. Typically, room temperature is about 20 °C to about 30 °C, or about 22 °C to about 27 °C, or about 25 °C.

[0059] A number of solvents may be employed in a chemical process, e.g., a reaction or crystallization. A suitable solvent may solubilize one or more of the reaction components, or, alternatively, the suitable solvent may facilitate the agitation of a suspension of one or more of the reaction components. A suitable solvent may be combined with one or more additional solvents Suitable solvents may be characterized according to properties, for example, protic, aprotic, polar, or non-polar. In some embodiments, the suitable solvent may be protic. In some embodiments, the suitable solvent may be aprotic. In some embodiments, the suitable solvent may be polar. In some embodiments, the suitable solvent may be non-polar. In some embodiments, the suitable solvent may be polar protic. In some embodiments, the suitable solvent may be polar aprotic. In some embodiments, the suitable solvent may be non-polar protic. In some embodiments, the suitable solvent may be non-polar aprotic. In some embodiments, suitable solvents may be selected from, but not limited to, water, an ether, an ester, an alcohol, a haloalkane, a ketone, or a mixture thereof. In some embodiments, the suitable solvent may be an alcohol. In some embodiments, the alcohol is selected from, but not limited to, methanol, ethanol, propanol, isopropanol, 1-butanol, 2-butanol, i-butyl alcohol, and tert-butanol. In some embodiments, the suitable solvent may be selected from, but not limited to, 2- nitroethanol, 2-fluoroethanol, 2,2,2-trifluoroethanol, ethylene glycol, 2-m ethoxy ethanol, 2- ethoxy ethanol, diethylene glycol, 1-, 2-, or 3 -pentanol, neo-pentyl alcohol, t-pentyl alcohol, diethylene glycol monomethyl ether, diethylene glycol monoethyl ether, cyclohexanol, benzyl alcohol, phenol, or glycerol. In some embodiments, the suitable solvent may be an ether. In someembodiments, the ether is selected from, but not limited to, tetrahydrofuran, 2- methyltetrahydrofuran, cyclopentyl methyl ether, tert -butyl methyl ether, di ethylether, 1,4- dioxane, glyme, and diglyme. In some embodiments, the suitable solvent may be an ester. In some embodiments, the ester is selected from, but not limited to, ethyl acetate, and isopropyl acetate. In some embodiments, the suitable solvent may be a ketone. In some embodiments, the ketone is selected from, but not limited to, acetone, methyl ethyl ketone, methyl isobutyl ketone, and hexachloroacetone. In some embodiments, the suitable solvent may be a haloalkane. In some embodiments, the haloalkane is selected from, but not limited to, di chloromethane, 1,2- di chloroethane, 1,2-di chloroethene, and chloroform. In some embodiments, the suitable solvent may be a nitrile. In some embodiments, the nitrile is selected from, but not limited to, acetonitrile and propionitrile. In some embodiments, the suitable solvent may be an alkane. In some embodiments, the alkane is selected from, but not limited to, heptane, hexane, pentane, and cyclohexane. In some embodiments, the suitable solvent may be an amide. In some embodiments, the amide is selected from, but not limited to, A,A-dimethylformamide, N,N- dimethylacetamide, .V-m ethyl pyrrolidinone, and formamide. In some embodiments, the suitable solvent may be an aromatic compound. In some embodiments, the aromatic compound is selected from, but not limited to, benzene, toluene, ethylbenzene, pyridine and xylene. In some embodiments, the suitable solvent may be water. In some embodiments, the suitable solvent may be ammonia or acetic acid. In some embodiments, the suitable solvent may be dimethylsulfoxide. In some embodiments, the solvent may be a mixture of a protic and / or an aprotic solvent. In some embodiments, the solvent may be a mixture of a protic and / or aprotic solvent and water. At least the aforementioned solvents provide a solvent means for preparing a solid-state form of the compound of Formula (I). At least the aforementioned solvents provide a solvent means for preparing an amorphous solid-state form of the compound of Formula (I). At least the aforementioned solvents provide a solvent means for preparing a crystalline solid-state form of the compound of Formula (I).

[0060] The amount of solvent employed in a chemical process, e.g., a reaction or crystallization, may be referred to herein as a number of “volumes” or “vol” or “V.” For example, a material may be referred to as being suspended in 10 volumes (or 10 vol or 10V) of a solvent. In this context, this expression would be understood to mean milliliters of the solvent per gram of the material being suspended, such that suspending 5 grams of a material in 10volumes of a solvent means that the solvent is used in an amount of 10 milliliters (mL) of the solvent per gram of the material that is being suspended or, in this example, 50 mL of the solvent. In another context, the term “v / v” may be used to indicate the number of volumes of a solvent that are added to a liquid mixture based on the volume of that mixture. For example, adding solvent X (1.5 v / v) to a 100 mL reaction mixture would indicate that 150 mL of solvent X was added.

[0061] A process or step may be referred to herein as being carried out “overnight.” This refers to a time interval, e.g., for the process or step, that spans the time during the night, when that process or step may not be actively observed. This time interval is about 8 to about 24 hours, or about 10-18 hours, typically about 16 hours.

[0062] As used herein, the term “reduced pressure” refers to a pressure that is less than atmospheric pressure. For example, a reduced pressure employed, for example in the context of drying conditions, is about 10 mbar to about 50 mbar, preferably 30-50 mbar.

[0063] As used herein, and unless indicated otherwise, the term “wet cake” refers to a crystalline form or solid that was not dried using any conventional techniques to remove residual solvent. Examples of such conventional techniques can be, but are not limited to, evaporation, vacuum drying, oven drying, drying under nitrogen flow, etc.

[0064] In general, a solid-state form ( .g., solid-state salts forms described herein), such as a crystal form or amorphous form, may be referred to herein as being characterized by graphical data “as depicted in,” “as shown in,” substantially as depicted in,” or “substantially as shown in.” . This will be understood to describe the solid-state form of the compound represented by Formula (I), or a solvate thereof, characterized with the graphical data having such small variations. Such data include, for example, powder X-ray diffractograms and solid- state NMR spectra. As is well-known in the art, the graphical data potentially provides additional technical information to further define the respective solid-state form (a so-called “fingerprint”) which cannot necessarily be described by reference to numerical values or peak positions alone. Such graphical representations of data may be subject to small variations, e.g., in peak relative intensities and peak positions due to certain factors such as, but not limited to, variations in instrument response and variations in sample concentration and purity.

[0065] A crystal is composed of atoms periodically arranged in a 3D space (i.e., a repeating pattern) while in amorphous materials atoms are randomly distributed in the 3D space(z.e., no long-range order). As a result, the X-ray diffractogram of a crystalline material will display narrow peaks of high intensity due the fact that the x-rays are scattered in only certain directions (due to the periodic arrangement of the atoms). In contrast, the X-ray diffractogram of an amorphous material generally displays broad peaks (halo pattern) of low intensity because the x-rays are scattered in many different directions leading to large bumps distributed over a wide range (2 Theta).

[0066] A crystal form of the compound represented by Formula (I), or a solvate thereof, referred to herein as being characterized by graphical data “as depicted in” or “as substantially depicted in” a Figure will thus be understood to include any crystal forms of the compound represented by Formula (I), or a solvate thereof, characterized with the graphical data having such small variations in comparison with the Figure.

[0067] In addition, where a reference is made to a Figure, it is permissible to, and this document includes and contemplates, the selection of any number of data points illustrated in the figure that uniquely define that crystalline form, within any associated and recited margin of error, for purposes of identification.

[0068] As used herein, the term “stability” generally refers to the tendency of a material to resist change or decomposition in its natural environment, or when exposed to air, heat, light, humidity, pressure, or other natural conditions, or due to internal reaction. In some embodiments, the material is exposed to heat (e. ., about 30 °C, about 40 °C, about 50 °C, about 60 °C, about 70 °C, about 80 °C) in a stability determination. In some embodiments, the material is exposed to humidity (e.g., 75% RH) in a stability determination. In some embodiments, the material is exposed to heat and humidity (e.g., about 40 °C and about 75% RH) in a stability determination.

[0069] As used herein and unless otherwise indicated, the terms “polymorph” and “polymorphic form” refer to solid crystalline forms of a compound or complex. In some embodiments, polymorphic forms include, but are not limited to, crystalline, amorphous, solvate, or hydrate. Different polymorphs of the same compound can exhibit different and / or improved physical, chemical and / or spectroscopic properties. Different physical properties include, but are not limited to stability (e.g., to heat or light), compressibility and density (important in formulation and product manufacturing), and dissolution rates (which can affect bioavailability).

[0070] As used herein, a polymorphic form may be described by reference to patterns, spectra, or other graphical data as “substantially” shown or depicted in a figure, or by one ormore data points. It will be appreciated that patterns, spectra, and other graphical data can be shifted in their positions, relative intensities, or other values due to a number of factors. For example, in the crystallographic and powder X-ray diffraction arts, shifts in peak positions or the relative intensities of one or more peaks of a pattern can occur because of, without limitation, the equipment used, the sample preparation protocol, preferred packing and orientations, the radiation source, operator error, method and length of data collection, or the like.

[0071] The occurrence of different polymorphs is possible for some compounds. A single compound may give rise to a variety of solids having distinct physical properties, such as X-ray diffraction patterns, infrared absorption spectra, and NMR spectra. This variation in solid forms may be significant and may result in differences with respect to bioavailability, stability, and other differences for formulated pharmaceutical products.

[0072] While the existence and possible numbers of polymorphic forms for a given pharmaceutical compound cannot be predicted, different polymorphs can possess different properties such as stability, solubility, melting point, or compressibility. As a result, new forms of a pharmaceutically useful compound may provide an opportunity to improve its characteristics, and ultimately its performance. Further, discovery of additional polymorphic forms, including solvate polymorphs, may help in the identification of the polymorphic content of a batch of an active pharmaceutical ingredient. For example, in some cases, different polymorphs of the same drug can exhibit very different solubility and different dissolution rates.

[0073] Differences in stability can result from changes in chemical reactivity (e.g, differential oxidation, such that a dosage form discolors more rapidly when comprised of one polymorph than when comprised of another polymorph) or mechanical characteristics (e.g, tablets crumble on storage as a kinetically favored polymorph converts to thermodynamically more stable polymorph) or both (e.g., tablets of one polymorph are more susceptible to breakdown at high humidity). Different physical properties of polymorphs can affect their processing. For example, one polymorph might be more likely to form solvates or might be more difficult to filter or wash free of impurities than another due to, for example, the shape or size distribution of particles of it.

[0074] Polymorphs of a molecule can be obtained by a number of methods. Such methods include, but are not limited to, melt recrystallization, melt cooling, solvent recrystallization, desolvation, rapid evaporation, rapid cooling, slow cooling, vapor diffusion andsublimation. Polymorphs can be detected, identified, classified and characterized using well- known techniques such as, but not limited to, differential scanning calorimetry (DSC), thermogravimetry (TG), X-ray powder diffractometry (XRPD), single crystal X-ray diffractometry, vibrational spectroscopy, solution calorimetry, solid-state nuclear magnetic resonance (NMR), infrared (IR) spectroscopy, Raman spectroscopy, hot stage optical microscopy, scanning electron microscopy (SEM), electron crystallography and quantitative analysis, particle size analysis (PSA), surface area analysis, solubility, and rate of dissolution.

[0075] Different solid-state forms can be characterized by scattering techniques, e.g., x- ray powder diffraction (XRPD) pattern, by spectroscopic methods, e.g., infrared absorption fingerprint, Raman absorption fingerprint, nuclear magnetic resonance (e.g., NMR, solid-state NMR) spectroscopy (e.g.,1H,13C,19F), and by thermal techniques, e.g, differential scanning calorimetry (DSC) or thermogravimetric analysis (TGA). Described herein are polymorphs (solid-state forms) of the compound represented by Formula (I). These solid-state forms and their distinct crystal structures and physical properties are characterized by TGA, DSC (measurement of melting point and thermal behavior), XRPD, and NMR such as proton NMR spectrum (XH NMR).

[0076] As used herein to refer to the spectra or data presented in graphical form (e.g., XRPD, IR, Raman and NMR spectra), and unless otherwise indicated, the term “peak” refers to a peak or other special feature not attributable to background noise.

[0077] Generally, a diffraction angle (20, “2 theta”) in X-ray powder diffractometry may have a variation in the range of ± 0.2°. Therefore, the aforementioned diffraction angle values should be understood as including values in the range of about ± 0.2°. Accordingly, the solid- state forms described here includes not only crystals whose peak diffraction angles in powder X- ray diffractometry completely coincide with each other, but also crystals whose peak diffraction angles coincide with each other with an error of about ± 0.2°. Therefore, in the present specification, the phrase “having a diffraction peak at a diffraction angle (20 ± 0.2°) of 8.0°” means “having a diffraction peak at a diffraction angle (29) of 7.8° to 8.2° ” In some embodiments, the diffraction angle may have a variation in the range of ± 0.1°. Therefore, in the present specification, the phrase “having a diffraction peak at a diffraction angle (20 ± 0.1°) of 8.0°” means “having a diffraction peak at a diffraction angle (20) of 7.9° to 8.1°. ’’Although the intensities of peaks in the x-ray powder diffraction patterns of different batches of a compoundmay vary slightly, the peak locations are characteristic for a specific polymorphic form. In some embodiments, the XRPD peak pattern may vary due to measurement errors, differing measurement conditions, and may display variations in peak intensity (z.e., identical order of intensity of peaks are not required). Alternatively, the term “about” means within an acceptable standard error of the mean. The relative intensities of the XRPD peaks can vary depending on the sample preparation technique, crystal size distribution, various filters used, the sample mounting procedure, and the particular instrument employed. Moreover, instrument variation and other factors can affect the 2-theta values. Therefore, the term “substantially” in the context of XRPD is meant to encompass that any peak assignment can vary by plus or minus about 0.2°. In some embodiments, any peak assignment can vary by plus or minus about 0.1°. Moreover, new peaks may be observed, or existing peaks may disappear, depending on the type of the machine or the settings (for example, whether a Ni filter is used or not).

[0078] Generally, a DSC thermogram may have a variation in the range of ± 3 °C. Therefore, the temperature values should be understood as including values in the range of ± 3 °C.

[0079] In general, provided herein are solid-state forms of the compound represented by Formula (I), or a solvate thereof, that are substantially free of any other solid-state forms whether as individual forms or mixtures of other forms, unless indicated otherwise. For example, Form 1 of the compound represented by Formula (I) will be substantially free of other forms of compound represented by Formula (I), or a solvate thereof, which may include other solid-state forms (e.g., Forms 2-6) of the compound represented by Formula (I), or a solvate thereof, or mixtures thereof. As used herein, “substantially free of any solid-state forms” means that the solid-state form of the compound represented by Formula (I), or a solvate thereof, contains about 20% or less, about 10% or less, about 5% or less, about 2% or less, or about 1% or less, of any other solid-state form of the compound represented by Formula (I), or a solvate thereof, as measured, for example, by XRPD. In some embodiments, the solid-state form of the compound represented by Formula (I), or a solvate thereof, contains less than about 20%, less than about 10%, less than about 5%, less than about 4%, less than about 3%, less than about 2%, or less than about 1% of any other solid-state forms of the compound represented by Formula (I), or a solvate thereof, as measured, for example, by XRPD. Thus, a solid-state form of the compound represented by Formula (I), or a solvate thereof, described herein as substantially free of anyother solid-state forms would be understood to contain greater than 80% (w / w), greater than 90% (w / w), greater than 95% (w / w), greater than 98% (w / w), or greater than 99% (w / w) of the said solid-state forms of the compound represented by Formula (I), or a solvate thereof. Accordingly, in some embodiments, the described solid-state forms of the compound represented by Formula (I), or a solvate thereof, may contain from 1% to 20% (w / w), from 5% to 20% (w / w), or from 5% to 10% (w / w) of one or more other solid-state forms of the compound represented by Formula (I), or a solvate thereof.

[0080] As used herein, “substantially free” means that the solid-state forms of the present disclosure contain 20% (w / w) or less of any other solid-state forms, or, alternatively, of a specific polymorph of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the solid-state forms of the present disclosure contain 10% (w / w) or less, 5% (w / w) or less, 2% (w / w), 1% (w / w) or less of any other solid-state forms, or specific polymorphs of the compound represented by Formula (I), or a solvate thereof. In other embodiments, solid- state forms of the compound represented by Formula (I), or a solvate thereof, of the present disclosure contain from 1% to 20% (w / w), from 5% to 20% (w / w), or from 5% to 10% (w / w) of other solid-state forms, or of a specific polymorph of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the any other solid-state forms, or specific polymorphs of the compound represented by Formula (I), or a solvate thereof includes any amount of solid-state material which may be present as to be undetectable by conventional means.

[0081] As used herein and unless otherwise indicated, the term “substantially pure” when used to describe a polymorph of a compound means a solid-state form of the compound that comprises that polymorph and is substantially free of any other solid-state forms of the compound or other impurities. For example, Form 1 of the compound represented by Formula (I) will be substantially pure while being substantially free of other forms of compound represented by Formula (I), or a solvate thereof, which may be other solid-state forms (e.g., Forms 2-6) of the compound represented by Formula (I), or a solvate thereof, or mixtures thereof. A representative substantially pure polymorph comprises greater than about 80% by weight of one polymorphic form of the compound and less than about 20% by weight of other polymorphic forms of the compound or other impurities. In some embodiments, a representative substantially pure polymorph comprises greater than about 90% by weight of one polymorphic form of thecompound and less than about 10% by weight of the other polymorphic forms of the compound or other impurities. In some embodiments, a representative substantially pure polymorph comprises greater than about 95% by weight of one polymorphic form of the compound and less than about 5% by weight of any other solid-state forms of the compound or other impurities. In some embodiments, a representative substantially pure polymorph comprises greater than about 97% by weight of one polymorphic form of the compound and less than about 3% by weight of any other solid-state forms of the compound or other impurities. In some embodiments, a representative substantially pure polymorph comprises greater than about 98% by weight of one polymorphic form of the compound and less than about 2% by weight of any other solid-state forms of the compound or other impurities. In some embodiments, a representative substantially pure polymorph comprises greater than about 99% by weight of one polymorphic form of the compound and less than about 1% by weight of any other solid-state forms of the compound or other impurities. In some embodiments, a representative substantially pure polymorph comprises greater than about 99.5% by weight of one polymorphic form of the compound and less than about 0.5% by weight of any other solid-state forms of the compound or other impurities. In some embodiments, a representative substantially pure polymorph comprises greater than about 99.8% by weight of one polymorphic form of the compound and less than about 0.2% by weight of any other solid-state forms of the compound or other impurities. In some embodiments, a representative substantially pure polymorph comprises greater than about 99.9% by weight of one polymorphic form of the compound and less than about 0.1% by weight of any other solid- state forms of the compound or other impurities. In some embodiments, a representative substantially pure polymorph comprises greater than about 99.95% by weight of one polymorphic form of the compound and less than about 0.05% by weight of any other solid-state forms of the compound or other impurities. In some embodiments, a representative substantially pure polymorph comprises one polymorphic form of the compound and any other solid-state forms of the compound or other impurities are undetectable.

[0082] In some embodiments, a crystalline or amorphous form that is “pure,” i.e., substantially free of other crystalline or amorphous forms or other impurities, contains less than about 10 percent by weight of one or more other crystalline or amorphous form or other impurities. In some embodiments, a crystalline or amorphous form that is “pure,”, contains less than about 5 percent by weight of one or more other crystalline or amorphous form or otherimpurities. In some embodiments, a crystalline or amorphous form that is “pure,” contains less than about 3 percent by weight of one or more other crystalline or amorphous form or other impurities. In some embodiments, a crystalline or amorphous form that is “pure,” contains less than about 1 percent by weight of one or more other crystalline or amorphous form or other impurities.

[0083] The content of solid-state forms is typically measured by any suitable method , for example XRPD, solid-state NMR, IR, Raman, or DSC.

[0084] Crystalline and partially crystalline solid forms may be prepared by a variety of methods including, but not limited to, for example, crystallization or recrystallization from a suitable solvent mixture; sublimation; growth from a melt; solid-state transformation from another phase; crystallization from a supercritical fluid; antisolvent addition; slurrying at various temperatures (e.g., at room temperature, at 10 °C, at 15 °C, at 40 °C, at 50 °C, at 70 °C); solid vapor diffusion; liquid vapor diffusion; evaporation; slow cooling, polymer induced crystallization; milling; spray freezing; spray congealing; lyophilization; and humidity induced crystallization. Techniques for crystallization or recrystallization of crystalline and partially crystalline solid forms of a solvent mixture include, but are not limited to, for example, evaporation of the solvent; decreasing the temperature of the solvent mixture; crystal seeding of a supersaturated solvent mixture of the compound thereof; crystal seeding a supersaturated solvent mixture of the compound thereof; freeze drying the solvent mixture; temperature cycling (e.g., cycling through two temperature extremes, typically at relatively high rates of change); and adding anti-solvents (countersolvents) to the solvent mixture. As used herein, the term “antisolvent” refers to a liquid that, when combined with a solution of the solid-state form of the compound represented by Formula (I), or a solvate thereof, reduces solubility of the solid-state form of the compound represented by Formula (I), or a solvate thereof, in the solution, causing crystallization or precipitation in some instances spontaneously, and in other instances with additional steps, such as seeding, cooling, scratching and / or concentrating. Crystals of drugs, including polymorphs, methods of preparation, and characterization of drug crystals, are discussed in Solid-State Chemistry of Drugs, S. R. Byrn, R. R. Pfeiffer, and J. G. Stowell, 2nd Edition, SSCI, West Lafayette, Ind. (1999). In a crystallization technique in which solvent is employed, the solvent(s) are typically chosen based on one or more factors including, but not limited to, for example, solubility of the compound; crystallization technique utilized; and vaporpressure of the solvent. Combinations of solvents may be employed. For example, the compound may be solubilized in a first solvent to afford a solution to which antisolvent is then added to decrease the solubility of the solid-state form of the compound represented by Formula (I), or a solvate thereof, in the solution and precipitate the formation of crystals. An antisolvent is a solvent in which a compound has low solubility. In one method that can be used in preparing crystals, a compound can be suspended and / or stirred in a suitable solvent to afford a slurry, which may be heated to promote dissolution. A cooled crystallization mixture may be filtered under vacuum and the isolated solid product washed with a suitable solvent, such as, for example, cold recrystallization solvent. After being washed, the product may be dried under a nitrogen purge to afford the desired solid form. After being washed, the product may be dried under vacuum to afford the desired solid form.

[0085] The term “solvate” as used herein refers to a physical association of the solid-state form of the compound represented by Formula (I) with solvent molecule(s). This physical association may involve varying degrees of ionic and covalent bonding including, but not limited to, hydrogen bonding. In certain instances, the solvate will be capable of isolation. “Solvate” encompasses both solution-phase and isolatable solvates. A “hydrate” as used herein is a solvate in which the solvent molecule(s) are water molecules (H2O). In certain instances, the hydrate form is a hemihydrate form, a monohydrate form, a sesquihydrate form, a dihydrate form, a trihydrate form, a tetrahydrate form, a pentahydrate form, a hexahydrate form, a heptahydrate form, an octahydrate form, a nonahydrate form, or a decahydrate form.

[0086] As used herein, a crystal form that is “essentially free” of water and / or solvent in the crystal lattice has a quantity of water and / or solvent in the crystal lattice which is, in some embodiments, approximately near the limit of detection, in some other embodiments approximately at the limit of detection, and in some other embodiments approximately below the limit of detection for solvent and / or water in the crystal lattice, when measured using a conventional solid-state analytical technique. In some embodiments, the solid-state analytical technique used to determine the quantity of water and / or solvent in the crystal lattice is thermogravimetric analysis. In some embodiments, the solid-state analytical technique used to determine the quantity of water and / or solvent in the crystal lattice is Karl Fischer analysis. In some embodiments, a crystal form which is “essentially free” of water and / or solvent in the crystal lattice has a water and / or solvent content which is less than about 5%, less than about 4%,less than about 3%, less than about 2%, less than about 1%, less than about 0.9%, less than about 0.8%, less than about 0.7%, less than about 0.6%, less than about 0.5%, less than about 0.4%, less than about 0.3%, less than about 0.2%, less than about 0.1%, less than about 0.05%, or less than about 0.01%, of the total weight of the crystal form.Solid-state forms of the compound of Formula (I)

[0087] The present disclosure encompasses solid-state forms of the compound represented by Formula (I):or a solvate thereof.Amorphous form

[0088] Provided herein, in part, is an amorphous solid-state form of the compound represented by Formula (I), or a solvate thereof, and pharmaceutical compositions comprising said solid-state form. In some embodiments, the amorphous solid-state form of the compound represented by Formula (I), or a solvate thereof, of the disclosure is substantially free of any other forms of the compound represented by Formula (I), or a solvate thereof, or of specific polymorphic forms of the compound represented by Formula (I), or a solvate thereof, respectively.

[0089] Provided herein is an amorphous solid-state form of the compound represented byFormula (I):solvates thereof.

[0090] In some embodiments, the amorphous solid-state form of the compound has an XRPD pattern substantially as shown in FIG. 14B.

[0091] In some embodiments, the compound represented by Formula (I) is in a hydrate form (the compound of Formula ( n FO). For example, the hydrate form is a hemihydrate form, a monohydrate form, a sesquihydrate form, a dihydrate form, a trihydrate form, a tetrahydrate form, a pentahydrate form, a hexahydrate form, a heptahydrate form, an octahydrate form, a nonahydrate form, or a decahydrate form. In some embodiments, the hydrate form is a hemihydrate form, a monohydrate form, a sesquihydrate form, a dihydrate form, a trihydrate form, or a tetrahydrate form. In some embodiments, the hydrate form is a monohydrate.

[0092] In some embodiments, the amorphous solid-state form of the compound is prepared by a process comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) warming the mixture of the compound represented by Formula (I) and a solvent to provide a clear solution;(iii) cooling the resulting solution;(iv) lyophilizing the resulting solution to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the amorphous solid-state form.

[0093] In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent up to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 45 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 40 °C. In some embodiments, the process comprises warming the mixture of thecompound represented by Formula (I) and a solvent to about 35 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 30 °C.

[0094] In some embodiments, the solvent is selected from the group consisting of 1- butanol, 1,2-di chloroethene, methyl ethyl ketone, 2-ethoxy ethanol, 2-methyltetrahydrofuran, 2- propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, N,N’ -dimethylformamide, dioxane, methanol-water, methyl isobutyl ketone and dichloromethane, or mixtures thereof. In some embodiments, the solvent is selected from the group consisting of 1 -butanol, 1,2-di chloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2-propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, and N,N’ -dimethylformamide, or mixtures thereof. In some embodiments, the solvent is dioxane. At least the aforementioned solvents provide a solvent means for preparing an amorphous solid-state form of the compound of Formula (I).

[0095] In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent up to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -25 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -20 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -15 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -10 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -5 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about 0 °C.

[0096] In some embodiments, the amorphous solid-state form of the compound is substantially pure.

[0097] In some embodiments, the amorphous solid-state form of the compound has a chemical purity of greater than 75% by weight. In some embodiments, the amorphous solid-state form of the compound has a chemical purity of greater than 80% by weight. In some embodiments, the amorphous solid-state form of the compound has a chemical purity of greaterthan 85% by weight. In some embodiments, the amorphous solid-state form of the compound has a chemical purity of greater than 90% by weight. In some embodiments, the amorphous solid- state form of the compound has a chemical purity of greater than 95% by weight. In some embodiments, the amorphous solid-state form of the compound has a chemical purity of greater than 96% by weight. In some embodiments, the amorphous solid-state form of the compound has a chemical purity of greater than 97% by weight. In some embodiments, the amorphous solid- state form of the compound has a chemical purity of greater than 98% by weight. In some embodiments, the amorphous solid-state form of the compound has a chemical purity of greater than 99% by weight.

[0098] In some embodiments, the amorphous solid-state form of the compound has no more than about 10 mol%, no more than about 9 mol%, no more than about 8 mol%, no more than about 7 mol%, no more than about 6 mol%, no more than about 5 mol%, no more than about 4 mol%, no more than about 3 mol%, no more than about 2 mol%, or no more than about 1 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the amorphous solid-state Form 1 of the compound has no more than about 10 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the amorphous solid-state Form 1 of the compound has no more than about 9 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the amorphous solid-state Form 1 of the compound has no more than about 8 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the amorphous solid- state Form 1 of the compound has no more than about 7 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the amorphous solid-state Form 1 of the compound has no more than about 6 mol% of other solid- state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the amorphous solid-state Form 1 of the compound has no more than about 5 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the amorphous solid-state Form 1 of the compound has no more than about 4 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the amorphous solid-state Form 1 of the compound has no more than about 3 mol% of other solid-state forms of the compound represented by Formula(I), or a solvate thereof. In some embodiments, the amorphous solid-state Form 1 of the compound has no more than about 2 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the amorphous solid- state Form 1 of the compound has no more than about 1 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof.

[0099] Also provided herein are pharmaceutical compositions comprising the amorphous solid-state form of the compound represented by Formula (I) and a pharmaceutically acceptable excipient or carrier.[000100] In some embodiments, the amorphous solid-state form is present in the composition in an amount of at least about 80% by weight. In some embodiments, the amorphous solid-state form is present in the composition in an amount of at least about 85% by weight. In some embodiments, the amorphous solid-state form is present in the composition in an amount of at least about 90% by weight. In some embodiments, the amorphous solid-state form is present in the composition in an amount of at least about 95% by weight. In some embodiments, the amorphous solid-state form is present in the composition in an amount of at least about 96% by weight. In some embodiments, the amorphous solid-state form is present in the composition in an amount of at least about 97% by weight. In some embodiments, the amorphous solid-state form is present in the composition in an amount of at least about 98% by weight. In some embodiments, the amorphous solid-state form is present in the composition in an amount of at least about 99% by weight.[000101] Also provided herein are pharmaceutical compositions consisting essentially of the amorphous solid-state form of the compound represented by Formula (I) and a pharmaceutically acceptable excipient or carrier.[000102] In some embodiments, provided herein is a pharmaceutical composition comprising the amorphous form of the compound represented by Formula (I), which is in the form of a capsule. In some embodiments, provided herein is a pharmaceutical composition comprising the amorphous form of the compound represented by Formula (I), which is in the form of a tablet.[000103] In some embodiments, provided herein is a pharmaceutical composition which is in the form of a capsule or tablet containing about 20 mg to about 1500 mg of the amorphous form of the compound represented by Formula (I). In some embodiments, provided herein is apharmaceutical composition which is in the form of a capsule or tablet containing about 20 mg to about 1200 mg of the amorphous form of the compound represented by Formula (I).[0001041 Infurther embodiments, this disclosure provides methods of making, isolating, and characterizing the amorphous solid-state form.[000105] Also provided herein are processes for preparing the amorphous solid-state form described herein, comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) warming the mixture of the compound represented by Formula (I) and a solvent to provide a clear solution;(iii) cooling the resulting solution;(iv) lyophilizing the resulting solution to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the amorphous solid-state form.[000106] In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent up to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 45 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 40 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 35 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 30 °C.[000107] In some embodiments, the solvent is selected from the group consisting of 1- butanol, 1,2-di chloroethene, methyl ethyl ketone, 2-ethoxy ethanol, 2-methyltetrahydrofuran, 2- propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, N,N’ -dimethylformamide, dioxane, methanol-water, methyl isobutyl ketone, and dichloromethane, or mixtures thereof. In some embodiments, the solvent is selected from the group consisting of 1 -butanol, 1,2-di chloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2-propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, and N,N’ -dimethylformamide, or mixtures thereof. In some embodiments, the solvent is dioxane. At least the aforementioned solvents provide a solvent means for preparing an amorphous solid-state form of the compound of Formula (I).[000108] In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent up to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -25 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -20 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -15 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -10 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -5 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about 0 °C.Crystalline forms[000109] Provided herein, in part, are crystalline solid-state forms of the compound represented by Formula (I), or a solvate thereof, and pharmaceutical compositions comprising these solid-state forms and mixtures thereof. In some embodiments, the crystalline solid-state form of the compound represented by Formula (I), or a solvate thereof, of the disclosure is substantially free of any other forms of the compound represented by Formula (I), or a solvate thereof, or of specific polymorphic forms of the compound represented by Formula (I), or a solvate thereof, respectively.[000110] In some embodiments, the solid-state form of the compound represented by Formula (I) is in a hydrate form (the compound of Formula ( nFhO). For example, the hydrate form is a hemihydrate form, a monohydrate form, a sesquihydrate form, a dihydrate form, a trihydrate form, a tetrahydrate form, a pentahydrate form, a hexahydrate form, a heptahydrate form, an octahydrate form, a nonahydrate form, or a decahydrate form. In some embodiments, the hydrate form is a hemihydrate form, a monohydrate form, a sesquihydrate form, a dihydrate form, a trihydrate form, or a tetrahydrate form. In some embodiments, the hydrate form is a monohydrate.[000111] In further embodiments, this disclosure provides methods of making, isolating, and characterizing the crystalline solid-state forms.Form 1[000112] Provided herein, in part, is Form 1 of a crystalline solid-state form of the compound represented by Formula (I):or a solvate thereof.[000113] In some embodiments, the crystalline solid-state Form 1 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 6.68°, about 19.36°, and about 21.89°.[000114] In some embodiments, the crystalline solid-state Form 1 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 6.7°, about 19.4°, and about 21.9°.[000115] In some embodiments, the crystalline solid-state Form 1 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 6.68°, about 12.82°, about 17.22°, about 19.36°, and about 21.89°.[000116] In some embodiments, the crystalline solid-state Form 1 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 6.7°, about 12.8°, about 17.2°, about 19.4°, and about 21.9°.[000117] In some embodiments, the crystalline solid-state Form 1 has an X-ray powder XRPD pattern comprising peaks, in terms of 2-theta, at about 6.68°, about 12.82°, about 16.48°, about 17.22°, about 17.80°, about 19.36, and about 21.89°.[000118] In some embodiments, the crystalline solid-state Form 1 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 6.7°, about 12.8°, about 16.5°, about 17.2°, about 17.8°, about 19.4, and about 21.9°.[000119] In some embodiments, the crystalline solid-state Form 1 has an XRPD pattern substantially as shown in FIG. 1.[000120] In some embodiments, the crystalline solid-state Form 1 has a thermogravimetric (“TG”) / differential scanning calorimetry (“DSC”) thermogram substantially as shown in FIG. 2.[000121] In some embodiments, the crystalline solid-state Form 1 has an endothermic peak at about 137 °C.[000122] In some embodiments, the crystalline solid-state Form 1 has a differential scanning calorimetry (DSC) thermogram comprising an endothermic peak at about 137 °C.[000123] In some embodiments, the crystalline solid-state Form 1 has a melting onset temperature of about 134 °C.[000124] In some embodiments, the crystalline solid-state Form 1 has a differential scanning calorimetry (DSC) thermogram comprising a melting onset temperature of about 134 °C.[000125] In some embodiments, the crystalline solid-state Form 1 has a DSC thermogram substantially as shown in FIG. 3. In some embodiments, the crystalline solid-state Form 1 has a DSC thermogram substantially as shown in FIG. 4. In some embodiments, the crystalline solid- state Form 1 has a DSC thermogram substantially as shown in FIG. 5.[000126] In some embodiments, the crystalline solid-state Form 1 has a dynamic vapor sorption (“DVS”) isotherm plot substantially as shown in FIG. 6.[000127] In some embodiments, the crystalline solid-state Form 1 has a DVS kinetic plot substantially as shown in FIG. 7.[000128] In some embodiments, the crystalline solid-state Form 1 has a Fourier-transform infrared spectroscopy (“FT-IR”) spectrum substantially as shown in FIG. 9.[000129] In some embodiments, the crystalline solid-state Form 1 has a 'H nuclear magnetic resonance (NMR) spectrum substantially as shown in FIG. 10.[000130] In some embodiments, the crystalline solid-state Form 1 of the compound is prepared by a process comprising:(i) reacting a compound of Formula A3:with a compound of Formula B2:oa first solvent to provide a mixture;(ii) wanning and then cooling the mixture;(iii) adding a second solvent and an aqueous solution to the mixture to provide a second mixture comprising (a) an aqueous layer and (b) a second layer comprising the first and second solvents;(iv) separating the aqueous layer from the second layer to provide a separated layer comprising the first and second solvents;(v) adding a third solvent to the separated layer to result in a solid precipitate; and (v) isolating the solid precipitate to obtain the crystalline solid-state form.[000131] In some embodiments, the first solvent is selected from the group consisting of tetrahydrofuran (THF), 2-MeTHF, acetonitrile, N-methyl pyrrolidinone, dimethylacetamide, dimethylformamide, dimethyl sulfoxide, isopropyl alcohol, ethyl alcohol, and methyl alcohol. In some embodiments, the first solvent is isopropyl alcohol. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 1 of the compound of Formula (I).[000132] In some embodiments, the reacting further comprises a base. In some embodiments, the base is selected from the group consisting of sodium carbonate, potassium carbonate, cesium carbonate, N,N-diisopropylethylamine, triethylamine, and 1,8- diazabicylco[5.4.0]undecane. In some embodiments, the base is selected from the group consisting of sodium carbonate, potassium carbonate, and cesium carbonate. In some embodiments, the base is potassium carbonate.[000133] In some embodiments, the process comprises warming the mixture to about 40 °C to about 90 °C. In some embodiments, the process comprises warming the mixture to about 50 °C to about 80 °C. In some embodiments, the process comprises warming the mixture to about 55 °C to about 75 °C. In some embodiments, the process comprises warming the mixture to about 45 °C. In some embodiments, the process comprises warming the mixture to about 50 °C. In some embodiments, the process comprises warming the mixture to about 55 °C. In some embodiments, the process comprises warming the mixture to about 60 °C. In some embodiments, the process comprises warming the mixture to about 65 °C. In some embodiments, the processcomprises warming the mixture to about 70 °C. In some embodiments, the process comprises warming the mixture to about 75 °C. In some embodiments, the process comprises warming the mixture to about 80 °C. In some embodiments, the process comprises warming the mixture to about 85 °C. In some embodiments, the process comprises warming the mixture to about 90 °C. [000134] In some embodiments, the process comprises cooling the mixture to about 0 °C to about 35 °C. In some embodiments, the process comprises cooling the mixture to about 15 °C to about 35 °C. In some embodiments, the process comprises cooling the mixture to about 0 °C. In some embodiments, the process comprises cooling the mixture to about 5 °C. In some embodiments, the process comprises cooling the mixture to about 10 °C. In some embodiments, the process comprises cooling the mixture to about 15 °C. In some embodiments, the process comprises cooling the mixture to about 20 °C. In some embodiments, the process comprises cooling the mixture to about 25 °C. In some embodiments, the process comprises cooling the mixture to about 30 °C. In some embodiments, the process comprises cooling the mixture to about 35 °C.[000135] In some embodiments, the second solvent is selected from the group consisting of butyl alcohol, isopropyl alcohol, butyl acetate, isopropyl acetate, methyl isoamyl ketone, propyl alcohol, chloroform, methyl isobutyl ketone, ethyl acetate, methyl propyl ketone, and methyl ethyl ketone. In some embodiments, the second solvent is ethyl acetate. In some embodiments, the second solvent is isopropyl acetate. In some embodiments, the aqueous solution is brine solution. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 1 of the compound of Formula (I).[000136] In some embodiments, the third solvent is selected from the group consisting of cyclohexane, heptane, hexane, methyl -tert-butyl ether, pentane, and toluene. In some embodiments, the third solvent is heptane. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 1 of the compound of Formula (I).[000137] In some embodiments, the process further comprises drying the solid precipitate. In some embodiments, the drying occurs at c'. ., about 20 °C to about 80 °C, about 20 °C to about 50 °C, about 20 °C to about 40 °C, about 20 °C, about 25 °C, about 30 °C, about 35 °C, about 40 °C, about 45 °C, about 50 °C, about 55 °C, about 60 °C, about 65 °C, about 70 °C, about 75 °C, or about 80 °C.[000138] In some embodiments, the crystalline solid-state Form 1 of the compound is prepared by a process comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) warming the mixture of the compound represented by Formula (I) and a solvent to provide a clear solution;(iii) cooling the resulting solution;(iv) evaporating the resulting solution to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the crystalline solid-state form.[000139] In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent up to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 45 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 40 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 35 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 30 °C.[000140] In some embodiments, the solvent is selected from the group consisting of 1- butanol, 1,2-di chloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2- propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, N,N’ -dimethylformamide, dioxane, methanol-water, methyl isobutyl ketone, and dichloromethane, or mixtures thereof. In some embodiments, the solvent is selected from the group consisting of 1 -butanol, 1,2-dichloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2-propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, and N,N’ -dimethylformamide, or mixtures thereof. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 1 of the compound of Formula (I).[000141] In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent up to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -30 °C. In some embodiments, the process comprises cooling the solution of thecompound represented by Formula (I) and a solvent to about -25 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -20 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -15 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -10 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -5 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about 0 °C.[000142] In some embodiments, the crystalline solid-state Form 1 of the compound is substantially pure.[000143] In some embodiments, the crystalline solid-state Form 1 of the compound has a chemical purity of greater than 75% by weight. In some embodiments, the crystalline solid-state Form 1 of the compound has a chemical purity of greater than 80% by weight. In some embodiments, the crystalline solid-state Form 1 of the compound has a chemical purity of greater than 85% by weight. In some embodiments, the crystalline solid-state Form 1 of the compound has a chemical purity of greater than 90% by weight. In some embodiments, the crystalline solid- state Form 1 of the compound has a chemical purity of greater than 95% by weight. In some embodiments, the crystalline solid-state Form 1 of the compound has a chemical purity of greater than 96% by weight. In some embodiments, the crystalline solid-state Form 1 of the compound has a chemical purity of greater than 97% by weight. In some embodiments, the crystalline solid- state Form 1 of the compound has a chemical purity of greater than 98% by weight. In some embodiments, the crystalline solid-state Form 1 of the compound has a chemical purity of greater than 99% by weight.[000144] In some embodiments, the crystalline solid-state Form 1 of the compound has no more than about 10 mol%, no more than about 9 mol%, no more than about 8 mol%, no more than about 7 mol%, no more than about 6 mol%, no more than about 5 mol%, no more than about 4 mol%, no more than about 3 mol%, no more than about 2 mol%, or no more than about 1 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 1 of the compound has no more than about 10 mol% of other solid-state forms of the compound represented by Formula (I), or asolvate thereof. In some embodiments, the crystalline solid-state Form 1 of the compound has no more than about 9 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 1 of the compound has no more than about 8 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 1 of the compound has no more than about 7 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 1 of the compound has no more than about 6 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 1 of the compound has no more than about 5 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 1 of the compound has no more than about 4 mol% of other solid- state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 1 of the compound has no more than about 3 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 1 of the compound has no more than about 2 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 1 of the compound has no more than about 1 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof.[000145] Also provided herein are pharmaceutical compositions comprising the crystalline solid-state Form 1 of the compound represented by Formula (I) and a pharmaceutically acceptable excipient or carrier.[000146] In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 80% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 85% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 90% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 95% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 96% by weight. In some embodiments, the crystalline solid-state form is present in the composition in anamount of at least about 97% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 98% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 99% by weight.[000147] Also provided herein are pharmaceutical compositions consisting essentially of the crystalline solid-state Form 1 of the compound represented by Formula (I) and a pharmaceutically acceptable excipient or carrier.[000148] In some embodiments, provided herein is a pharmaceutical composition comprising the crystalline solid-state Form 1 of the compound represented by Formula (I), which is in the form of a capsule. In some embodiments, provided herein is a pharmaceutical composition comprising the crystalline solid-state Form 1 of the compound represented by Formula (I), which is in the form of a tablet.[000149] In some embodiments, provided herein is a pharmaceutical composition which is in the form of a capsule or tablet containing about 20 mg to about 1500 mg of the crystalline solid-state Form 1 of the compound represented by Formula (I). In some embodiments, provided herein is a pharmaceutical composition which is in the form of a capsule or tablet containing about 20 mg to about 1200 mg of the crystalline solid-state Form 1 of the compound represented by Formula (I).[000150] Also provided herein are processes for preparing the crystalline solid-state Form 1 described herein, comprising:(i) reacting a compound of Formula A3: mula B2:first solvent to provide a mixture;(ii) warming and then cooling the mixture;(iii) adding a second solvent and an aqueous solution to the mixture to provide a second mixture comprising (a) an aqueous layer and (b) a second layer comprising the first and second solvents;(iv) separating the aqueous layer from the second layer to provide a separated layer comprising the first and second solvents;(v) adding a third solvent to the separated layer to result in a solid precipitate; and (v) isolating the solid precipitate to obtain the crystalline solid-state form.[000151] In some embodiments, the first solvent is isopropyl alcohol. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 1 of the compound of Formula (I).[000152] In some embodiments, the reacting further comprises a base. In some embodiments, the base is potassium carbonate.[000153] In some embodiments, the process comprises warming the mixture to about 40 °C to about 90 °C. In some embodiments, the process comprises warming the mixture to about 50 °C to about 80 °C. In some embodiments, the process comprises warming the mixture to about 55 °C to about 75 °C. In some embodiments, the process comprises warming the mixture to about 45 °C. In some embodiments, the process comprises warming the mixture to about 50 °C. In some embodiments, the process comprises warming the mixture to about 55 °C. In some embodiments, the process comprises warming the mixture to about 60 °C. In some embodiments, the process comprises warming the mixture to about 65 °C. In some embodiments, the process comprises warming the mixture to about 70 °C. In some embodiments, the process comprises warming the mixture to about 75 °C. In some embodiments, the process comprises warming the mixture to about 80 °C. In some embodiments, the process comprises warming the mixture to about 85 °C. In some embodiments, the process comprises warming the mixture to about 90 °C. [000154] In some embodiments, the process comprises cooling the mixture to about 0 °C to about 35 °C. In some embodiments, the process comprises cooling the mixture to about 15 °C to about 35 °C. In some embodiments, the process comprises cooling the mixture to about 0 °C. In some embodiments, the process comprises cooling the mixture to about 5 °C. In some embodiments, the process comprises cooling the mixture to about 10 °C. In some embodiments, the process comprises cooling the mixture to about 15 °C. In some embodiments, the processcomprises cooling the mixture to about 20 °C. Tn some embodiments, the process comprises cooling the mixture to about 25 °C. In some embodiments, the process comprises cooling the mixture to about 30 °C. In some embodiments, the process comprises cooling the mixture to about 35 °C.[000155] In some embodiments, the second solvent is isopropyl acetate. In some embodiments, the aqueous solution is brine solution.[000156] In some embodiments, the third solvent is heptane. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 1 of the compound of Formula (I).[000157] In some embodiments, the process further comprises drying the solid precipitate. In some embodiments, the drying occurs at e.g., about 20 °C to about 80 °C, about 20 °C to about 50 °C, about 20 °C to about 40 °C, about 20 °C, about 25 °C, about 30 °C, about 35 °C, about 40 °C, about 45 °C, about 50 °C, about 55 °C, about 60 °C, about 65 °C, about 70 °C, about 75 °C, or about 80 °C.[000158] Also provided herein are processes for preparing the crystalline solid-state Form 1 described herein, comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) warming the mixture of the compound represented by Formula (I) and a solvent to provide a clear solution;(iii) cooling the resulting solution;(iv) evaporating the resulting solution to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the crystalline solid-state form.[000159] In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent up to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 45 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 40 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 35 °C. In some embodiments, theprocess comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 30 °C.[0001601 Insome embodiments, the solvent is selected from the group consisting of 1- butanol, 1,2-di chloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2- propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, N,N’ -dimethylformamide, dioxane, methanol-water, methyl isobutyl ketone, and dichloromethane, or mixtures thereof. In some embodiments, the solvent is selected from the group consisting of 1 -butanol, 1,2-dichloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2-propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, and N,N’ -dimethylformamide, or mixtures thereof. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 1 of the compound of Formula (I).[000161] In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent up to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -25 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -20 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -15 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -10 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -5 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about 0 °C.Form 2[000162] Provided herein, in part, is Form 2 of a crystalline solid-state form of the compound represented by Formula (I):or a solvate thereof.[000163] In some embodiments, the crystalline solid-state Form 2 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 18.62°, about 19.11°, and about 20.60°.[000164] In some embodiments, the crystalline solid-state Form 2 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 18.6°, about 19.1°, and about 20.6°.[000165] In some embodiments, the crystalline solid-state Form 2 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 11.00°, about 17.62°, about 18.62°, about 19.11°, and about 20.60°.[000166] In some embodiments, the crystalline solid-state Form 2 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 11 .0°, about 17.6°, about 18.6°, about 19.1 °, and about 20.6°.[000167] In some embodiments, the crystalline solid-state Form 2 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 9.74°, about 9.98°, about 11.00°, about 17.62°, about 18.62°, about 19.11°, and about 20.60°.[000168] In some embodiments, the crystalline solid-state Form 2 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 9.7°, about 10.0°, about 11.0°, about 17.6°, about 18.6°, about 19.1°, and about 20.6°.[000169] In some embodiments, the crystalline solid-state Form 2 has an XRPD pattern substantially as shown in FIG. 16.[000170] In some embodiments, the crystalline solid-state Form 2 of the compound is prepared by a process comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) warming the mixture of the compound represented by Formula (I) and a solvent to provide a clear solution;(iii) cooling the resulting solution;(iv) evaporating the resulting solution to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the crystalline solid-state form.[000171] In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent up to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 45 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 40 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 35 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 30 °C.[000172] In some embodiments, the solvent is selected from the group consisting of 1- butanol, 1,2-di chloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2- propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, N,N’ -dimethylformamide, dioxane, methanol-water, methyl isobutyl ketone, and dichloromethane, or mixtures thereof. In some embodiments, the solvent is selected from the group consisting of 1 -butanol, 1,2-dichloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2-propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, and N,N’ -dimethylformamide, or mixtures thereof. In some embodiments, the solvent is dioxane. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 2 of the compound of Formula (I).[000173] In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent up to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -25 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -20 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -15 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and asolvent to about -10 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -5 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about 0 °C.[000174] In some embodiments, the crystalline solid-state Form 2 of the compound is substantially pure.[000175] In some embodiments, the crystalline solid-state Form 2 of the compound has a chemical purity of greater than 75% by weight. In some embodiments, the crystalline solid-state Form 2 of the compound has a chemical purity of greater than 80% by weight. In some embodiments, the crystalline solid-state Form 2 of the compound has a chemical purity of greater than 85% by weight. In some embodiments, the crystalline solid-state Form 2 of the compound has a chemical purity of greater than 90% by weight. In some embodiments, the crystalline solid- state Form 2 of the compound has a chemical purity of greater than 95% by weight. In some embodiments, the crystalline solid-state Form 2 of the compound has a chemical purity of greater than 96% by weight. In some embodiments, the crystalline solid-state Form 2 of the compound has a chemical purity of greater than 97% by weight. In some embodiments, the crystalline solid- state Form 2 of the compound has a chemical purity of greater than 98% by weight. In some embodiments, the crystalline solid-state Form 2 of the compound has a chemical purity of greater than 99% by weight.[000176] In some embodiments, the crystalline solid-state Form 2 of the compound has no more than about 10 mol%, no more than about 9 mol%, no more than about 8 mol%, no more than about 7 mol%, no more than about 6 mol%, no more than about 5 mol%, no more than about 4 mol%, no more than about 3 mol%, no more than about 2 mol%, or no more than about 1 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 2 of the compound has no more than about 10 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 2 of the compound has no more than about 9 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 2 of the compound has no more than about 8 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 2 of thecompound has no more than about 7 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof In some embodiments, the crystalline solid-state Form 2 of the compound has no more than about 6 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 2 of the compound has no more than about 5 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 2 of the compound has no more than about 4 mol% of other solid- state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 2 of the compound has no more than about 3 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 2 of the compound has no more than about 2 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 2 of the compound has no more than about 1 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof.[000177] Also provided herein are pharmaceutical compositions comprising the crystalline solid-state Form 2 of the compound represented by Formula (I) and a pharmaceutically acceptable excipient or carrier.[000178] In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 80% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 85% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 90% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 95% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 96% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 97% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 98% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 99% by weight.[000179] Also provided herein are pharmaceutical compositions consisting essentially of the crystalline solid-state Form 2 of the compound represented by Formula (I) and a pharmaceutically acceptable excipient or carrier.[000180] In some embodiments, provided herein is a pharmaceutical composition comprising the crystalline solid-state Form 2 of the compound represented by Formula (I), which is in the form of a capsule. In some embodiments, provided herein is a pharmaceutical composition comprising the crystalline solid-state Form 2 of the compound represented by Formula (I), which is in the form of a tablet.[000181] In some embodiments, provided herein is a pharmaceutical composition which is in the form of a capsule or tablet containing about 20 mg to about 1500 mg of the crystalline solid-state Form 2 of the compound represented by Formula (I). In some embodiments, provided herein is a pharmaceutical composition which is in the form of a capsule or tablet containing about 20 mg to about 1200 mg of the crystalline solid-state Form 2 of the compound represented by Formula (I).[000182] Also provided herein are processes for preparing the crystalline solid-state Form 2 described herein, comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) warming the mixture of the compound represented by Formula (I) and a solvent to provide a clear solution;(iii) cooling the resulting solution;(iv) evaporating the resulting solution to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the crystalline solid-state form.[000183] In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent up to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 45 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 40 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 35 °C. In some embodiments, theprocess comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 30 °C.[0001841 Insome embodiments, the solvent is selected from the group consisting of 1- butanol, 1,2-di chloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2- propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, N,N’ -dimethylformamide, dioxane, methanol-water, methyl isobutyl ketone, and dichloromethane, or mixtures thereof. In some embodiments, the solvent is selected from the group consisting of 1 -butanol, 1,2-dichloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2-propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, and N,N’ -dimethylformamide, or mixtures thereof. In some embodiments, the solvent is dioxane. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 2 of the compound of Formula (I).[000185] In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent up to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -25 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -20 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -15 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -10 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -5 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about 0 °C.Form 3[000186] Provided herein, in part, is Form 3 of a crystalline solid-state form of the compound represented by Formula (I):or a solvate thereof.[000187] In some embodiments, the crystalline solid-state Form 3 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 13.24°, about 16.86°, and about 22.64°.[000188] In some embodiments, the crystalline solid-state Form 3 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 13.2°, about 16.9°, and about 22.6°.[000189] In some embodiments, the crystalline solid-state Form 3 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 11.08°, about 13.24°, about 16.86°, about 22.64°, and about 23.42°.[000190] In some embodiments, the crystalline solid-state Form 3 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 11.1°, about 13.2°, about 16.9°, about 22.6°, and about 23.4°.[000191] In some embodiments, the crystalline solid-state Form 3 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 11.08°, about 13.24°, about 16.58°, about 16.86°, about 22.64°, and about 23.42°.[000192] In some embodiments, the crystalline solid-state Form 3 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 11.1°, about 13.2°, about 16.6°, about 16.9°, about 22.6°, and about 23.4°.[000193] In some embodiments, the crystalline solid-state Form 3 has an XRPD pattern substantially as shown in FIG. 17.[000194] In some embodiments, the crystalline solid-state Form 3 of the compound is prepared by a process comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) warming the mixture of the compound represented by Formula (I) and a solvent to provide a clear solution;(iii) cooling the resulting solution;(iv) evaporating the resulting solution to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the crystalline solid-state form.[000195] In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent up to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 45 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 40 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 35 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 30 °C.[000196] In some embodiments, the solvent is selected from the group consisting of 1- butanol, 1,2-di chloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2- propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, N,N’ -dimethylformamide, dioxane, methanol-water, methyl isobutyl ketone, and dichloromethane, or mixtures thereof. In some embodiments, the solvent is selected from the group consisting of 1 -butanol, 1,2-dichloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2-propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, and N,N’ -dimethylformamide, or mixtures thereof. In some embodiments, the solvent is a mixture of methanol and water (e.g., 80:20 methanol and water v / v). At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 3 of the compound of Formula (I).[000197] In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent up to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -25 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -20 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -15 °C. In some embodiments, theprocess comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -10 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -5 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about 0 °C.[000198] In some embodiments, the crystalline solid-state Form 3 of the compound is substantially pure.[000199] In some embodiments, the crystalline solid-state Form 3 of the compound has a chemical purity of greater than 75% by weight. In some embodiments, the crystalline solid-state Form 3 of the compound has a chemical purity of greater than 80% by weight. In some embodiments, the crystalline solid-state Form 3 of the compound has a chemical purity of greater than 85% by weight. In some embodiments, the crystalline solid-state Form 3 of the compound has a chemical purity of greater than 90% by weight. In some embodiments, the crystalline solid- state Form 3 of the compound has a chemical purity of greater than 95% by weight. In some embodiments, the crystalline solid-state Form 3 of the compound has a chemical purity of greater than 96% by weight. In some embodiments, the crystalline solid-state Form 3 of the compound has a chemical purity of greater than 97% by weight. In some embodiments, the crystalline solid- state Form 3 of the compound has a chemical purity of greater than 98% by weight. In some embodiments, the crystalline solid-state Form 3 of the compound has a chemical purity of greater than 99% by weight.[000200] In some embodiments, the crystalline solid-state Form 3 of the compound has no more than about 10 mol%, no more than about 9 mol%, no more than about 8 mol%, no more than about 7 mol%, no more than about 6 mol%, no more than about 5 mol%, no more than about 4 mol%, no more than about 3 mol%, no more than about 2 mol%, or no more than about 1 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 3 of the compound has no more than about 10 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 3 of the compound has no more than about 9 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 3 of the compound has no more than about 8 mol% of other solid-state forms of the compound represented byFormula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 3 of the compound has no more than about 7 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 3 of the compound has no more than about 6 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 3 of the compound has no more than about 5 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 3 of the compound has no more than about 4 mol% of other solid- state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 3 of the compound has no more than about 3 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 3 of the compound has no more than about 2 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 3 of the compound has no more than about 1 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof.[000201] Also provided herein are pharmaceutical compositions comprising the crystalline solid-state Form 3 of the compound represented by Formula (I) and a pharmaceutically acceptable excipient or carrier.[000202] In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 80% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 85% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 90% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 95% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 96% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 97% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 98% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 99% by weight.[000203] Also provided herein are pharmaceutical compositions consisting essentially of the crystalline solid-state Form 3 of the compound represented by Formula (I) and a pharmaceutically acceptable excipient or carrier.[000204] In some embodiments, provided herein is a pharmaceutical composition comprising the crystalline solid-state Form 3 of the compound represented by Formula (I), which is in the form of a capsule. In some embodiments, provided herein is a pharmaceutical composition comprising the crystalline solid-state Form 3 of the compound represented by Formula (I), which is in the form of a tablet.[000205] In some embodiments, provided herein is a pharmaceutical composition which is in the form of a capsule or tablet containing about 20 mg to about 1500 mg of the crystalline solid-state Form 3 of the compound represented by Formula (I). In some embodiments, provided herein is a pharmaceutical composition which is in the form of a capsule or tablet containing about 20 mg to about 1200 mg of the crystalline solid-state Form 3 of the compound represented by Formula (I).[000206] Also provided herein are processes for preparing the crystalline solid-state Form 3 described herein, comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) warming the mixture of the compound represented by Formula (I) and a solvent to provide a clear solution;(iii) cooling the resulting solution;(iv) evaporating the resulting solution to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the crystalline solid-state form.[000207] In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent up to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 45 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 40 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 35 °C. In some embodiments, theprocess comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 30 °C.[0002081 Insome embodiments, the solvent is selected from the group consisting of 1- butanol, 1,2-di chloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2- propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, N,N’ -dimethylformamide, dioxane, methanol-water, methyl isobutyl ketone, and dichloromethane, or mixtures thereof. In some embodiments, the solvent is selected from the group consisting of 1 -butanol, 1,2-dichloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2-propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, and N,N’ -dimethylformamide, or mixtures thereof. In some embodiments, the solvent is a mixture of methanol and water (e.g., 80:20 methanol and water v / v). At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 3 of the compound of Formula (I).[000209] In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent up to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -25 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -20 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -15 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -10 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -5 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about 0 °C.Form 4[000210] Provided herein, in part, is Form 4 of a crystalline solid-state form of the compound represented by Formula (I):or a solvate thereof.[000211] In some embodiments, the crystalline solid-state Form 4 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 15.80°, about 17.46°, and about 19.74°.[000212] In some embodiments, the crystalline solid-state Form 4 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 15.8°, about 17.5°, and about 19.7°.[000213] In some embodiments, the crystalline solid-state Form 4 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 9.98°, about 15.80°, about 17.46°, about 19.74°, and about 21.43°.[000214] In some embodiments, the crystalline solid-state Form 4 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 10.0°, about 15.8°, about 17.5°, about 19.7°, and about 21.4°.[000215] In some embodiments, the crystalline solid-state Form 4 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 9.98°, about 15.80°, about 17.46°, about 18.99°, about 19.74°, about 21.43°, and about 22.60°.[000216] In some embodiments, the crystalline solid-state Form 4 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 10.0°, about 15.8°, about 17.5°, about 19.0°, about 19.7°, about 21.4°, and about 22.6°.[000217] In some embodiments, the crystalline solid-state Form 4 has an XRPD pattern substantially as shown in FIG. 18.[000218] In some embodiments, the crystalline solid-state Form 4 of the compound is prepared by a process comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) warming the mixture of the compound represented by Formula (I) and a solvent to provide a clear solution;(iii) cooling the resulting solution;(iv) evaporating the resulting solution to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the crystalline solid-state form.[000219] In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent up to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 45 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 40 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 35 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 30 °C.[000220] In some embodiments, the solvent is selected from the group consisting of 1- butanol, 1,2-di chloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2- propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, N,N’ -dimethylformamide, dioxane, methanol-water, methyl isobutyl ketone, and dichloromethane, or mixtures thereof. In some embodiments, the solvent is selected from the group consisting of 1 -butanol, 1,2-dichloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2-propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, and N,N’ -dimethylformamide, or mixtures thereof. In some embodiments, the solvent is methyl isobutyl ketone. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 4 of the compound of Formula (I). [000221] In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent up to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -25 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -20 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -15 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and asolvent to about -10 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -5 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about 0 °C.[000222] In some embodiments, the crystalline solid-state Form 4 of the compound is substantially pure.[000223] In some embodiments, the crystalline solid-state Form 4 of the compound has a chemical purity of greater than 75% by weight. In some embodiments, the crystalline solid-state Form 4 of the compound has a chemical purity of greater than 80% by weight. In some embodiments, the crystalline solid-state Form 4 of the compound has a chemical purity of greater than 85% by weight. In some embodiments, the crystalline solid-state Form 4 of the compound has a chemical purity of greater than 90% by weight. In some embodiments, the crystalline solid- state Form 4 of the compound has a chemical purity of greater than 95% by weight. In some embodiments, the crystalline solid-state Form 4 of the compound has a chemical purity of greater than 96% by weight. In some embodiments, the crystalline solid-state Form 4 of the compound has a chemical purity of greater than 97% by weight. In some embodiments, the crystalline solid- state Form 4 of the compound has a chemical purity of greater than 98% by weight. In some embodiments, the crystalline solid-state Form 4 of the compound has a chemical purity of greater than 99% by weight.[000224] In some embodiments, the crystalline solid-state Form 4 of the compound has no more than about 10 mol%, no more than about 9 mol%, no more than about 8 mol%, no more than about 7 mol%, no more than about 6 mol%, no more than about 5 mol%, no more than about 4 mol%, no more than about 3 mol%, no more than about 2 mol%, or no more than about 1 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 4 of the compound has no more than about 10 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 4 of the compound has no more than about 9 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 4 of the compound has no more than about 8 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 4 of thecompound has no more than about 7 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof In some embodiments, the crystalline solid-state Form 4 of the compound has no more than about 6 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 4 of the compound has no more than about 5 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 4 of the compound has no more than about 4 mol% of other solid- state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 4 of the compound has no more than about 3 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 4 of the compound has no more than about 2 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 4 of the compound has no more than about 1 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof.[000225] Also provided herein are pharmaceutical compositions comprising the crystalline solid-state Form 4 of the compound represented by Formula (I) and a pharmaceutically acceptable excipient or carrier.[000226] In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 80% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 85% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 90% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 95% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 96% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 97% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 98% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 99% by weight.[000227] Also provided herein are pharmaceutical compositions consisting essentially of the crystalline solid-state Form 4 of the compound represented by Formula (I) and a pharmaceutically acceptable excipient or carrier.[000228] In some embodiments, provided herein is a pharmaceutical composition comprising the crystalline solid-state Form 4 of the compound represented by Formula (I), which is in the form of a capsule. In some embodiments, provided herein is a pharmaceutical composition comprising the crystalline solid-state Form 4 of the compound represented by Formula (I), which is in the form of a tablet.[000229] In some embodiments, provided herein is a pharmaceutical composition which is in the form of a capsule or tablet containing about 20 mg to about 1500 mg of the crystalline solid-state Form 4 of the compound represented by Formula (I). In some embodiments, provided herein is a pharmaceutical composition which is in the form of a capsule or tablet containing about 20 mg to about 1200 mg of the crystalline solid-state Form 4 of the compound represented by Formula (I).[000230] Also provided herein are processes for preparing the crystalline solid-state Form 4 described herein, comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) warming the mixture of the compound represented by Formula (I) and a solvent to provide a clear solution;(iii) cooling the resulting solution;(iv) evaporating the resulting solution to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the crystalline solid-state form.[000231] In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent up to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 45 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 40 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 35 °C. In some embodiments, theprocess comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 30 °C.[0002321 Insome embodiments, the solvent is selected from the group consisting of 1- butanol, 1,2-di chloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2- propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, N,N’ -dimethylformamide, dioxane, methanol-water, methyl isobutyl ketone, and dichloromethane, or mixtures thereof. In some embodiments, the solvent is selected from the group consisting of 1 -butanol, 1,2-dichloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2-propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, and N,N’ -dimethylformamide, or mixtures thereof. In some embodiments, the solvent is methyl isobutyl ketone. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 4 of the compound of Formula (I).[000233] In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent up to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -25 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -20 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -15 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -10 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -5 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about 0 °C.Form 5[000234] Provided herein, in part, is Form 5 of a crystalline solid-state form of the compound represented by Formula (I):or a solvate thereof.[000235] In some embodiments, the crystalline solid-state Form 5 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 15.29°, about 19.75°, and about 21.35°.[000236] In some embodiments, the crystalline solid-state Form 5 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 15.3°, about 19.8°, and about 21.4°.[000237] In some embodiments, the crystalline solid-state Form 5 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 9.60°, about 11.30°, about 15.29°, about 19.75°, and about 21.35°.[000238] In some embodiments, the crystalline solid-state Form 5 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 9.6°, about 11.3°, about 15.3°, about 19.8°, and about 21.4°.[000239] In some embodiments, the crystalline solid-state Form 5 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 9.60°, about 11.30°, about 13.31°, about 15.29°, about 18.76°, about 19.75°, and about 21.35°.[000240] In some embodiments, the crystalline solid-state Form 5 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 9.6°, about 11.3°, about 13.3°, about 15.3°, about 18.8°, about 19.8°, and about 21.4°.[000241] In some embodiments, the crystalline solid-state Form 5 has an XRPD pattern substantially as shown in FIG. 19.[000242] In some embodiments, the crystalline solid-state Form 5 of the compound is prepared by a process comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) warming the mixture of the compound represented by Formula (I) and a solvent to provide a clear solution;(iii) cooling the resulting solution;(iv) evaporating the resulting solution to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the crystalline solid-state form.[000243] In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent up to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 45 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 40 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 35 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 30 °C.[000244] In some embodiments, the solvent is selected from the group consisting of 1- butanol, 1,2-di chloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2- propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, N,N’ -dimethylformamide, dioxane, methanol-water, methyl isobutyl ketone, and dichloromethane, or mixtures thereof. In some embodiments, the solvent is selected from the group consisting of 1 -butanol, 1,2-dichloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2-propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, and N,N’ -dimethylformamide, or mixtures thereof. In some embodiments, the solvent is dichloromethane. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 5 of the compound of Formula (I). [000245] In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent up to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -25 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -20 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -15 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and asolvent to about -10 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -5 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about 0 °C.[000246] In some embodiments, the crystalline solid-state Form 5 of the compound is substantially pure.[000247] In some embodiments, the crystalline solid-state Form 5 of the compound has a chemical purity of greater than 75% by weight. In some embodiments, the crystalline solid-state Form 5 of the compound has a chemical purity of greater than 80% by weight. In some embodiments, the crystalline solid-state Form 5 of the compound has a chemical purity of greater than 85% by weight. In some embodiments, the crystalline solid-state Form 5 of the compound has a chemical purity of greater than 90% by weight. In some embodiments, the crystalline solid- state Form 5 of the compound has a chemical purity of greater than 95% by weight. In some embodiments, the crystalline solid-state Form 5 of the compound has a chemical purity of greater than 96% by weight. In some embodiments, the crystalline solid-state Form 5 of the compound has a chemical purity of greater than 97% by weight. In some embodiments, the crystalline solid- state Form 5 of the compound has a chemical purity of greater than 98% by weight. In some embodiments, the crystalline solid-state Form 5 of the compound has a chemical purity of greater than 99% by weight.[000248] In some embodiments, the crystalline solid-state Form 5 of the compound has no more than about 10 mol%, no more than about 9 mol%, no more than about 8 mol%, no more than about 7 mol%, no more than about 6 mol%, no more than about 5 mol%, no more than about 4 mol%, no more than about 3 mol%, no more than about 2 mol%, or no more than about 1 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 5 of the compound has no more than about 10 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 5 of the compound has no more than about 9 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 5 of the compound has no more than about 8 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 5 of thecompound has no more than about 7 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof In some embodiments, the crystalline solid-state Form 5 of the compound has no more than about 6 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 5 of the compound has no more than about 5 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 5 of the compound has no more than about 4 mol% of other solid- state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 5 of the compound has no more than about 3 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 5 of the compound has no more than about 2 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 5 of the compound has no more than about 1 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof.[000249] Also provided herein are pharmaceutical compositions comprising the crystalline solid-state Form 5 of the compound represented by Formula (I) and a pharmaceutically acceptable excipient or carrier.[000250] In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 80% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 85% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 90% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 95% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 96% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 97% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 98% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 99% by weight.[000251] Also provided herein are pharmaceutical compositions consisting essentially of the crystalline solid-state Form 5 of the compound represented by Formula (I) and a pharmaceutically acceptable excipient or carrier.[000252] In some embodiments, provided herein is a pharmaceutical composition comprising the crystalline solid-state Form 5 of the compound represented by Formula (I), which is in the form of a capsule. In some embodiments, provided herein is a pharmaceutical composition comprising the crystalline solid-state Form 5 of the compound represented by Formula (I), which is in the form of a tablet.[000253] In some embodiments, provided herein is a pharmaceutical composition which is in the form of a capsule or tablet containing about 20 mg to about 1500 mg of the crystalline solid-state Form 5 of the compound represented by Formula (I). In some embodiments, provided herein is a pharmaceutical composition which is in the form of a capsule or tablet containing about 20 mg to about 1200 mg of the crystalline solid-state Form 5 of the compound represented by Formula (I).[000254] Also provided herein are processes for preparing the crystalline solid-state Form 5 described herein, comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) warming the mixture of the compound represented by Formula (I) and a solvent to provide a clear solution;(iii) cooling the resulting solution;(iv) evaporating the resulting solution to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the crystalline solid-state form.[000255] In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent up to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 50 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 45 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 40 °C. In some embodiments, the process comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 35 °C. In some embodiments, theprocess comprises warming the mixture of the compound represented by Formula (I) and a solvent to about 30 °C.[0002561 Insome embodiments, the solvent is selected from the group consisting of 1- butanol, 1,2-di chloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2- propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, N,N’ -dimethylformamide, dioxane, methanol-water, methyl isobutyl ketone, and dichloromethane, or mixtures thereof. In some embodiments, the solvent is selected from the group consisting of 1 -butanol, 1,2-dichloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2-methyltetrahydrofuran, 2-propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, and N,N’ -dimethylformamide, or mixtures thereof. In some embodiments, the solvent is dichloromethane. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 5 of the compound of Formula (I).[000257] In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent up to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -30 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -25 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -20 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -15 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -10 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about -5 °C. In some embodiments, the process comprises cooling the solution of the compound represented by Formula (I) and a solvent to about 0 °C.Form 6[000258] Provided herein, in part, is Form 6 of a crystalline solid-state form of the compound represented by Formula (I):or a solvate thereof.[000259] In some embodiments, the crystalline solid-state Form 6 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 10.78°, about 18.60°, and about 18.81°.[000260] In some embodiments, the crystalline solid-state Form 6 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 10.8°, about 18.6°, and about 18.8°.[000261] In some embodiments, the crystalline solid-state Form 6 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 8.90°, about 10.78°, about 16.85°, about 18.60°, and about 18.81°.[000262] In some embodiments, the crystalline solid-state Form 6 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 8.9°, about 10.8°, about 16.9°, about 18.6°, and about 18.8°.[000263] In some embodiments, the crystalline solid-state Form 6 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 8.90°, about 10.78°, about 16.85°, about 18.60°, about 18.81°, about 20.58°, and about 21.41°.[000264] In some embodiments, the crystalline solid-state Form 6 has an XRPD pattern comprising peaks, in terms of 2-theta, at about 8.9°, about 10.8°, about 16.9°, about 18.6°, about 18.8°, about 20.6°, and about 21.4°.[000265] In some embodiments, the crystalline solid-state Form 6 has an XRPD pattern substantially as shown in FIG. 11.[000266] In some embodiments, the crystalline solid-state Form 6 of the compound is prepared by a process comprising:(i) reacting a compound of Formula A3:mula B2:first solvent to provide a mixture;(ii) warming and then cooling the mixture;(iii) adding a second solvent and an aqueous solution to the mixture to provide a second mixture comprising (a) an aqueous layer and (b) a second layer comprising the first and second solvents;(iv) separating the aqueous layer from the second layer to provide a separated layer comprising the first and second solvents;(v) adding a third solvent to the separated layer to result in a solid precipitate; and (v) isolating the solid precipitate to obtain the crystalline solid-state form.[000267] In some embodiments, the first solvent is isopropyl alcohol. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 6 of the compound of Formula (I).[000268] In some embodiments, the reacting further comprises a base. In some embodiments, the base is potassium carbonate.[000269] In some embodiments, the process comprises warming the mixture to about 40 °C to about 90 °C. In some embodiments, the process comprises warming the mixture to about 50 °C to about 80 °C. In some embodiments, the process comprises warming the mixture to about 55 °C to about 75 °C. In some embodiments, the process comprises warming the mixture to about 45 °C. In some embodiments, the process comprises warming the mixture to about 50 °C. In some embodiments, the process comprises warming the mixture to about 55 °C. In some embodiments, the process comprises warming the mixture to about 60 °C. In some embodiments, the process comprises warming the mixture to about 65 °C. In some embodiments, the processcomprises warming the mixture to about 70 °C. In some embodiments, the process comprises warming the mixture to about 75 °C. In some embodiments, the process comprises warming the mixture to about 80 °C. In some embodiments, the process comprises warming the mixture to about 85 °C. In some embodiments, the process comprises warming the mixture to about 90 °C. [000270] In some embodiments, the process comprises cooling the mixture to about 0 °C to about 35 °C. In some embodiments, the process comprises cooling the mixture to about 15 °C to about 35 °C. In some embodiments, the process comprises cooling the mixture to about 0 °C. In some embodiments, the process comprises cooling the mixture to about 5 °C. In some embodiments, the process comprises cooling the mixture to about 10 °C. In some embodiments, the process comprises cooling the mixture to about 15 °C. In some embodiments, the process comprises cooling the mixture to about 20 °C. In some embodiments, the process comprises cooling the mixture to about 25 °C. In some embodiments, the process comprises cooling the mixture to about 30 °C. In some embodiments, the process comprises cooling the mixture to about 35 °C.[000271] In some embodiments, the second solvent is selected from the group consisting of butyl alcohol, isopropyl alcohol, butyl acetate, isopropyl acetate, methyl isoamyl ketone, propyl alcohol, chloroform, methyl isobutyl ketone, ethyl acetate, methyl propyl ketone, and methyl ethyl ketone. In some embodiments, the second solvent is ethyl acetate. In some embodiments, the aqueous solution is brine solution. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 6 of the compound of Formula (I).[000272] In some embodiments, the third solvent is selected from the group consisting of cyclohexane, heptane, hexane, methyl -tert-butyl ether, pentane, and toluene. In some embodiments, the third solvent is heptane. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 6 of the compound of Formula (I).[000273] In some embodiments, the process further comprises drying the solid precipitate. In some embodiments, the drying occurs at an elevated temperature, e.g., about 30 °C to about 80 °C, about 40 °C to about 70 °C, about 50 °C to about 60 °C, about 30 °C, about 35 °C, about 40 °C, about 45 °C, about 50 °C, about 55 °C, about 60 °C, about 65 °C, about 70 °C, about 75 °C, or about 80 °C.[000274] In some embodiments, the crystalline solid-state Form 6 of the compound is prepared by a process comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) concentrating the mixture of the compound represented by Formula (I) and a solvent to provide a slurry;(iii) adding antisolvent to the slurry with agitation overnight;(iv) filtering the resultant slurry to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the crystalline solid-state form.[000275] In some embodiments, the solvent is selected from the group consisting of butyl alcohol, isopropyl alcohol, butyl acetate, isopropyl acetate, methyl isoamyl ketone, propyl alcohol, chloroform, methyl isobutyl ketone, ethyl acetate, methyl propyl ketone, and methyl ethyl ketone. In some embodiments, the solvent is ethyl acetate. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 6 of the compound of Formula (I).[000276] In some embodiments, the antisolvent is selected from the group consisting of cyclohexane, heptane, hexane, methyl -tert-butyl ether, pentane, and toluene. In some embodiments, the antisolvent is heptane. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 6 of the compound of Formula (I).[000277] In some embodiments, the crystalline solid-state Form 6 of the compound is substantially pure.[000278] In some embodiments, the crystalline solid-state Form 6 of the compound has a chemical purity of greater than 75% by weight. In some embodiments, the crystalline solid-state Form 6 of the compound has a chemical purity of greater than 80% by weight. In some embodiments, the crystalline solid-state Form 6 of the compound has a chemical purity of greater than 85% by weight. In some embodiments, the crystalline solid-state Form 6 of the compound has a chemical purity of greater than 90% by weight. In some embodiments, the crystalline solid- state Form 6 of the compound has a chemical purity of greater than 95% by weight. In some embodiments, the crystalline solid-state Form 6 of the compound has a chemical purity of greater than 96% by weight. In some embodiments, the crystalline solid-state Form 6 of the compound has a chemical purity of greater than 97% by weight. In some embodiments, the crystalline solid- state Form 6 of the compound has a chemical purity of greater than 98% by weight. In some embodiments, the crystalline solid-state Form 6 of the compound has a chemical purity of greater than 99% by weight.[000279] In some embodiments, the crystalline solid-state Form 6 of the compound has no more than about 10 mol%, no more than about 9 mol%, no more than about 8 mol%, no more than about 7 mol%, no more than about 6 mol%, no more than about 5 mol%, no more than about 4 mol%, no more than about 3 mol%, no more than about 2 mol%, or no more than about 1 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 6 of the compound has no more than about 10 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 6 of the compound has no more than about 9 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 6 of the compound has no more than about 8 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 6 of the compound has no more than about 7 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 6 of the compound has no more than about 6 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 6 of the compound has no more than about 5 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 6 of the compound has no more than about 4 mol% of other solid- state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 6 of the compound has no more than about 3 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 6 of the compound has no more than about 2 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof. In some embodiments, the crystalline solid-state Form 6 of the compound has no more than about 1 mol% of other solid-state forms of the compound represented by Formula (I), or a solvate thereof.[000280] Also provided herein are pharmaceutical compositions comprising the crystalline solid-state Form 6 of the compound represented by Formula (I) and a pharmaceutically acceptable excipient or carrier.[000281] In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 80% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 85% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 90% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 95% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 96% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 97% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 98% by weight. In some embodiments, the crystalline solid-state form is present in the composition in an amount of at least about 99% by weight.[000282] Also provided herein are pharmaceutical compositions consisting essentially of the crystalline solid-state Form 6 of the compound represented by Formula (I) and a pharmaceutically acceptable excipient or carrier.[000283] In some embodiments, provided herein is a pharmaceutical composition comprising the crystalline solid-state Form 6 of the compound represented by Formula (I), which is in the form of a capsule. In some embodiments, provided herein is a pharmaceutical composition comprising the crystalline solid-state Form 6 of the compound represented by Formula (I), which is in the form of a tablet.[000284] In some embodiments, provided herein is a pharmaceutical composition which is in the form of a capsule or tablet containing about 20 mg to about 1500 mg of the crystalline solid-state Form 6 of the compound represented by Formula (I). In some embodiments, provided herein is a pharmaceutical composition which is in the form of a capsule or tablet containing about 20 mg to about 1200 mg of the crystalline solid-state Form 6 of the compound represented by Formula (I).[000285] Also provided herein are processes for preparing the crystalline solid-state Form 6 described herein, comprising:(i) reacting a compound of Formula A3:mula B2:first solvent to provide a mixture;(ii) warming and then cooling the mixture;(iii) adding a second solvent and an aqueous solution to the mixture to provide a second mixture comprising (a) an aqueous layer and (b) a second layer comprising the first and second solvents;(iv) separating the aqueous layer from the second layer to provide a separated layer comprising the first and second solvents;(v) adding a third solvent to the separated layer to result in a solid precipitate; and (v) isolating the solid precipitate to obtain the crystalline solid-state form.[000286] In some embodiments, the first solvent is isopropyl alcohol. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 6 of the compound of Formula (I).[000287] In some embodiments, the reacting further comprises a base. In some embodiments, the base is potassium carbonate.[000288] In some embodiments, the process comprises warming the mixture to about 40 °C to about 90 °C. In some embodiments, the process comprises warming the mixture to about 50 °C to about 80 °C. In some embodiments, the process comprises warming the mixture to about 55 °C to about 75 °C. In some embodiments, the process comprises warming the mixture to about 45 °C. In some embodiments, the process comprises warming the mixture to about 50 °C. In some embodiments, the process comprises warming the mixture to about 55 °C. In some embodiments, the process comprises warming the mixture to about 60 °C. In some embodiments, the process comprises warming the mixture to about 65 °C. In some embodiments, the processcomprises warming the mixture to about 70 °C. In some embodiments, the process comprises warming the mixture to about 75 °C. In some embodiments, the process comprises warming the mixture to about 80 °C. In some embodiments, the process comprises warming the mixture to about 85 °C. In some embodiments, the process comprises warming the mixture to about 90 °C. [000289] In some embodiments, the process comprises cooling the mixture to about 0 °C to about 35 °C. In some embodiments, the process comprises cooling the mixture to about 15 °C to about 35 °C. In some embodiments, the process comprises cooling the mixture to about 0 °C. In some embodiments, the process comprises cooling the mixture to about 5 °C. In some embodiments, the process comprises cooling the mixture to about 10 °C. In some embodiments, the process comprises cooling the mixture to about 15 °C. In some embodiments, the process comprises cooling the mixture to about 20 °C. In some embodiments, the process comprises cooling the mixture to about 25 °C. In some embodiments, the process comprises cooling the mixture to about 30 °C. In some embodiments, the process comprises cooling the mixture to about 35 °C.[000290] In some embodiments, the second solvent is selected from the group consisting of butyl alcohol, isopropyl alcohol, butyl acetate, isopropyl acetate, methyl isoamyl ketone, propyl alcohol, chloroform, methyl isobutyl ketone, ethyl acetate, methyl propyl ketone, and methyl ethyl ketone. In some embodiments, the second solvent is ethyl acetate. In some embodiments, the aqueous solution is brine solution. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 6 of the compound of Formula (I).[000291] In some embodiments, the third solvent is selected from the group consisting of cyclohexane, heptane, hexane, methyl -tert-butyl ether, pentane, and toluene. In some embodiments, the third solvent is heptane. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 6 of the compound of Formula (I).[000292] In some embodiments, the process further comprises drying the solid precipitate. In some embodiments, the drying occurs at an elevated temperature, e.g., about 30 °C to about 80 °C, about 40 °C to about 70 °C, about 50 °C to about 60 °C, about 30 °C, about 35 °C, about 40 °C, about 45 °C, about 50 °C, about 55 °C, about 60 °C, about 65 °C, about 70 °C, about 75 °C, or about 80 °C.[000293] Also provided herein is a process for preparing the crystalline solid-state Form 6 described herein, comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) concentrating the mixture of the compound represented by Formula (I) and a solvent to provide a slurry;(iii) adding antisolvent to the slurry with agitation overnight;(iv) filtering the resultant slurry to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the crystalline solid-state form.[000294] In some embodiments, the solvent is selected from the group consisting of butyl alcohol, isopropyl alcohol, butyl acetate, isopropyl acetate, methyl isoamyl ketone, propyl alcohol, chloroform, methyl isobutyl ketone, ethyl acetate, methyl propyl ketone, and methyl ethyl ketone. In some embodiments, the solvent is ethyl acetate. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 6 of the compound of Formula (I).[000295] In some embodiments, the antisolvent is selected from the group consisting of cyclohexane, heptane, hexane, methyl -tert-butyl ether, pentane, and toluene. In some embodiments, the antisolvent is heptane. At least the aforementioned solvents provide a solvent means for preparing crystalline solid-state Form 6 of the compound of Formula (I).Solid-state polymorphism[000296] The occurrence of different polymorphs is possible for some compounds. A single compound may give rise to a variety of solids having distinct physical properties, such as X-ray diffraction patterns, infrared absorption spectra, and NMR spectra. This variation in solid forms may be significant and may result in differences with respect to bioavailability, stability, and other differences for formulated pharmaceutical products.[000297] The existence and possible numbers of polymorphic forms for a given compound cannot be predicted, and there are no “standard” procedures that can be used to prepare polymorphic forms of a substance. However, new forms of a pharmaceutically useful compound may provide an opportunity to improve the performance characteristics of pharmaceutical products. Further, discovery of additional polymorphic forms, including solvate polymorphs, may help in the identification of the polymorphic content of a batch of an active pharmaceutical ingredient. For example, in some cases, different forms of the same drug can exhibit very different solubility and different dissolution rates.[000298] Crystalline forms are characterized by scattering techniques, e.g., x-ray diffraction powder pattern, by spectroscopic methods, e.g., infra-red,13C nuclear magnetic resonance spectroscopy, and by thermal techniques, e.g., differential scanning calorimetry or differential thermal analysis. The compound of this disclosure is best characterized by the X-ray powder diffraction pattern determined in accordance with procedures that are known in the art. For a discussion of these techniques, see J. Haleblian, J. Pharm. Sci. 1975 64: 1269-1288, and J. Haleblian and W. McCrone, J. Pharm. Sci. 1969 58:91 1-929.[000299] The solid-state forms of the compound represented by Formula (I) according to the present disclosure may have advantageous physical, mechanical, chemical, or physicochemical properties selected from, but not limited to, chemical purity, polymorphic purity, flowability, solubility, dissolution rate, bioavailability, morphology or crystal habit, stability such as chemical stability as well as thermal and mechanical stability with respect to polymorphic conversion, stability towards dehydration and / or storage stability, a lower degree of hygroscopicity, low content of residual solvents, melting point, hardness, and advantageous processing and handling characteristics such as compressibility, or bulk density, process reproducibility, ease of handling, ease of manufacturing, shelf-life, and ease of formulation.Pharmaceutical compositions and kits[000300] Pharmaceutical formulations of the present disclosure contain any one or a combination of the crystalline solid-state forms of the compound represented by Formula (I) of the present disclosure. In addition to the active ingredient, the pharmaceutical formulations of the present disclosure can contain one or more excipients. Excipients are added to the formulation for a variety of purposes.[000301] These formulations include those suitable for oral, rectal, topical, buccal, parenteral (e.g., subcutaneous, intramuscular, intradermal, or intravenous) rectal, vaginal, or aerosol administration, although the most suitable form of administration in any given case will depend on the degree and severity of the condition being treated and on the nature of the particular solid-state form of the compound being used. For example, disclosed compositions may be formulated as a unit dose, and / or may be formulated for oral or subcutaneous administration.[000302] Exemplary pharmaceutical compositions may be used in the form of a pharmaceutical preparation, for example, in solid, semisolid, or liquid form, which contains oneor more of the solid-state forms of the compound represented by Formula (I), or a solvate thereof, described herein, as an active ingredient, in admixture with an organic or inorganic carrier or excipient suitable for external, enteral, or parenteral applications. The active ingredient may be compounded, for example, with the usual non-toxic, pharmaceutically acceptable carriers for tablets, pellets, capsules, suppositories, solutions, emulsions, suspensions, and any other form suitable for use. The active object solid-state form of the compound is included in the pharmaceutical composition in an amount sufficient to produce the desired effect upon the process or condition of the disease.[000303] In further embodiments, a pharmaceutical formulation of crystalline solid-state forms of the compound represented by Formula (I) is formulated for administration to a mammal, such as a human. Crystalline solid-state forms of the compound represented by Formula (I) can be formulated, for example, as a viscous liquid solution or suspension, such as a clear solution, for injection. The formulation can contain one or more solvents. A suitable solvent can be selected by considering the solvent's physical and chemical stability at various pH levels, viscosity (which would allow for syringe ability), fluidity, boiling point, miscibility, and purity. Suitable solvents include alcohol USP, benzyl alcohol NF, benzyl benzoate USP, and Castor oil USP. Additional substances can be added to the formulation such as buffers, solubilizers, and antioxidants, among others. Ansel et al, Pharmaceutical Dosage Forms and Drug Delivery Systems, 7th ed.[000304] The present disclosure encompasses a process to prepare said formulations of crystalline solid-state forms of the compound represented by Formula (I) by combining the crystalline solid-state forms prepared according to the present disclosure and at least one pharmaceutically acceptable excipient.[000305] Advantageously, described herein are kits for use by a e.g., a consumer in need of treatment of cancer. Such kits include a suitable dosage form such as those described above and instructions describing the method of using such dosage form to mediate, reduce or prevent inflammation. The instructions would direct the consumer or medical personnel to administer the dosage form according to administration known modes. Such kits could advantageously be packaged and sold in single or multiple kit units. An example of such a kit is a so-called blister pack. Blister packs are well known in the packaging industry and are being widely used for the packaging of pharmaceutical unit dosage forms (tablets, capsules, and the like). Blister packsgenerally consist of a sheet of relatively stiff material covered with a foil of a preferably transparent plastic material. During the packaging process recesses are formed in the plastic foil. The recesses have the size and shape of the tablets or capsules to be packed. Next, the tablets or capsules are placed in the recesses and the sheet of relatively stiff material is sealed against the plastic foil at the face of the foil which is opposite from the direction in which the recesses were formed. As a result, the tablets or capsules are sealed in the recesses between the plastic foil and the sheet. Preferably the strength of the sheet is such that the tablets or capsules can be removed from the blister pack by manually applying pressure on the recesses whereby an opening is formed in the sheet at the place of the recess. The tablet or capsule can then be removed via said opening.[000306] It may be desirable to provide a memory aid on the kit, e.g., in the form of numbers next to the tablets or capsules whereby the numbers correspond with the days of the regimen which the tablets or capsules so specified should be ingested. Another example of such a memory aid is a calendar printed on the card, e.g., as follows "First Week, Monday, Tuesday, . . . etc. . . . Second Week, Monday, Tuesday, . . . " etc. Other variations of memory aids will be readily apparent. A "daily dose" can be a single tablet or capsule or several pills or capsules to be taken on a given day. Also, a daily dose of a first compound can consist of one tablet or capsule while a daily dose of the second compound can consist of several tablets or capsules and vice versa. The memory aid should reflect this.[000307] At least Examples 1 and 2 and the aforementioned paragraphs provide a pharmaceutical composition comprising: (a) a means for inhibiting ULK1 and / or ULK2 kinase; and (b) a pharmaceutically acceptable excipient for treating cancer, wherein the cancer is selected from the group consisting of gastrointestinal stromal tumors, esophageal cancer, gastric cancer, melanomas, gliomas, glioblastomas, gynecological cancers, bladder cancer, pancreatic cancer, prostate cancer, lung cancers, breast cancers, renal cancers, hepatic cancers, osteosarcomas, Ewing sarcoma, multiple myelomas, cervical carcinomas, cancers that are metastatic to bone, papillary thyroid carcinoma, colorectal cancer, acute myeloid leukemia, relapsed acute myeloid leukemia, refractory acute myeloid leukemia, myelodysplastic syndrome, acute lymphocytic leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia, myeloproliferative neoplasms, and mantle cell lymphoma.[000308]Methods of use[000309] Solid-state forms described herein can act as inhibitors of autophagy useful in the treatment of a disorder in a patient in need thereof. The disorder, for example, can be a tumor, e.g., a solid tumor. The disorder may also be cancer.[000310] Exemplary cancers include but are not limited to gastrointestinal stromal tumors, esophageal cancer, gastric cancer, melanomas, gliomas, glioblastomas, gynecological cancers (including ovarian cancer, endometrial cancer, and uterine cancer), bladder cancer, pancreatic cancer, prostate cancer, lung cancers (including non-small cell lung cancer), breast cancers (including ER+ HER2- breast cancer and triple negative breast cancer), renal cancers, hepatic cancers, osteosarcomas, Ewing sarcoma, multiple myelomas, cervical carcinomas, cancers that are metastatic to bone, papillary thyroid carcinoma, colorectal cancer, acute myeloid leukemia, relapsed acute myeloid leukemia, refractory acute myeloid leukemia, myelodysplastic syndrome, acute lymphocytic leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia, myeloproliferative neoplasms, and mantle cell lymphoma.[000311] In some embodiments, provided herein are methods of treating a tumor in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of a solid-state compound described herein or pharmaceutically acceptable solvates thereof, or of a pharmaceutical composition described herein.[000312] In some embodiments, provided herein are methods of treating a disease or disorder in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of a solid-state form of the compound represented by Formula (I), or a solvate thereof, or a pharmaceutical composition comprising a solid-state form of the compound represented by Formula (I), or a solvate thereof.[000313] In some embodiments, the disease or disorder is cancer. In some embodiments, the cancer is selected from the group consisting of gastrointestinal stromal tumors, esophageal cancer, gastric cancer, melanomas, gliomas, glioblastomas, gynecological cancers (including ovarian cancer, endometrial cancer, and uterine cancer), bladder cancer, pancreatic cancer, prostate cancer, lung cancers (including non-small cell lung cancer), breast cancers (including ER+ HER2- breast cancer and triple negative breast cancer), renal cancers, hepatic cancers, osteosarcomas, Ewing sarcoma, multiple myelomas, cervical carcinomas, cancers that are metastatic to bone, papillary thyroid carcinoma, colorectal cancer, acute myeloid leukemia,relapsed acute myeloid leukemia, refractory acute myeloid leukemia, myelodysplastic syndrome, acute lymphocytic leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia, myeloproliferative neoplasms, and mantle cell lymphoma.[000314] In some embodiments, the method comprises administering to the patient one or more additional therapeutic agents.[000315] Also provided herein are solid-state forms of the compound represented by Formula (I), or a solvate thereof, or pharmaceutical compositions comprising a solid-state form of the compound represented by Formula (I), or a solvate thereof, for use in therapy.[000316] In some embodiments, provided herein are solid-state forms of the compound represented by Formula (I), or a solvate thereof, or a pharmaceutical composition comprising a solid-state form of the compound represented by Formula (I), or a solvate thereof, for use in treating a tumor in a patient in need thereof.[000317] In some embodiments, provided herein are solid-state forms of the compound represented by Formula (I), or a solvate thereof, or a pharmaceutical composition comprising a solid-state form of the compound represented by Formula (I), or a solvate thereof, for use in treating a disease or disorder in a patient in need thereof.[000318] In some embodiments, the disease or disorder is cancer. In some embodiments, the cancer is selected from the group consisting of gastrointestinal stromal tumors, esophageal cancer, gastric cancer, melanomas, gliomas, glioblastomas, gynecological cancers (including ovarian cancer, endometrial cancer, and uterine cancer), bladder cancer, pancreatic cancer, prostate cancer, lung cancers (including non-small cell lung cancer), breast cancers (including ER+ HER2- breast cancer and triple negative breast cancer), renal cancers, hepatic cancers, osteosarcomas, Ewing sarcoma, multiple myelomas, cervical carcinomas, cancers that are metastatic to bone, papillary thyroid carcinoma, colorectal cancer, acute myeloid leukemia, relapsed acute myeloid leukemia, refractory acute myeloid leukemia, myelodysplastic syndrome, acute lymphocytic leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia, myeloproliferative neoplasms, and mantle cell lymphoma.[000319] In some embodiments, the solid-state form or pharmaceutical composition for use further comprises administering to the patient one or more additional therapeutic agents.[000320] In some embodiments, the solid-state forms described herein are useful for the treatment of cancers caused by RAS mutation. In some embodiments, the cancer is caused by aKRAS mutation. Tn some embodiments, the cancer has additional mutations in tumor suppressor proteins, including mutations in TP53, PTEN, CDN2A / INK4A, p!6, or STAG2. In some embodiments, these additional mutations occur in one or more of TP53, PTEN, CDN2A / INK4A, pl 6, or STAG2. In some embodiments, the cancer is pancreatic ductal adenocarcinoma. In some embodiments, the cancer is lung cancer. In some embodiments, the cancer is colorectal. In some embodiments, the cancer is acute myeloid leukemia.[000321] In some embodiments, determination of cellular inhibition of autophagy by solid- state forms described herein is determined by monitoring of autophagic flux, for instance by monitoring inhibition of autophagy-mediated clearance of mCherry / GFP-LC3 fusion protein. In some embodiments, determination of cellular inhibition of autophagy by solid-state forms described herein is determined by monitoring of accumulation of autophagic proteins such as p62 or LC-3. In some embodiments, determination of cellular inhibition of autophagy by solid- state forms described herein is determined by decreased clearance of luciferase-tagged LC3 protein. In some embodiments, determination of cellular inhibition of autophagy by solid-state forms described herein is determined by monitoring decreases in cellular autophagosomes, for instance by measurement of fluorescent puncta with the autophagosome marker Cyto-ID.[000322] In some embodiments, cellular inhibition of ULK kinase by solid-state forms described herein is determined by inhibition of phosphorylation of cellular ULK substrates including ATG13, ATG14, Beclin 1, or STING either in tumor cells or in non-tumor host tissues. In some embodiments, cellular inhibition of ULK kinase by solid-state forms described herein is determined in host tissues including immune cells.[000323] In some embodiments, in vivo inhibition of autophagy by solid-state forms described herein is determined by inhibition of phosphorylation of cellular ULK substrates including ATG13, ATG14, Beclin 1, or STING either in tumor cells or in non-tumor host tissues. In some embodiments, in vivo inhibition of ULK kinase by solid-state forms described herein is determined in host tissues including immune cells. In some embodiments, the in vivo inhibition of autophagic flux by solid-state forms described herein can be used as a pharmacodynamic model for monitoring the kinetics and extent of such ULK inhibition. In some embodiments, in vivo inhibition of ULK kinase by solid-state forms described herein is determined in pancreatic cancer-bearing animals. In some embodiments, in vivo inhibition of ULK kinase by solid-state forms described herein is determined in lung cancer-bearing animals. In some embodiments, invivo inhibition of ULK kinase is determined in colorectal cancer-bearing animals. In some embodiments, in vivo inhibition of autophagy by solid-state forms described herein is determined by inhibition of autophagic flux in tumor cells, or in non-tumor host tissues by monitoring inhibition of autophagosome formation, or by accumulation of autophagic proteins such as p62 or LC-III. In some embodiments, in vivo inhibition of autophagy is determined in host tissues including immune cells. In some embodiments, the in vivo inhibition of autophagic flux can be used as a pharmacodynamic model for monitoring the kinetics and extent of such ULK inhibition.[000324] In some embodiments, inhibition of autophagy and anti-tumor activity by solid- state forms described herein are evaluated in xenograft studies utilizing human RAS mutant cell lines in immunocompromised mice, for instance in SCID or nude mice. In some embodiments, inhibition of autophagy and anti-tumor activity by solid-state forms described herein are evaluated in xenograft studies utilizing human RAS mutant patient-derived tumor xenografts (PDXs) in immunocompromised mice, for instance in SCID or nude mice. In some embodiments, xenograft studies include evaluation of solid-state forms described herein in pancreatic cancer models. In some embodiments, xenograft studies include evaluation of solid- state forms described herein in lung cancer models. In some embodiments, xenograft studies include evaluation of solid-state forms described herein in colorectal cancer models. In some embodiments, xenograft studies include evaluation of solid-state forms described herein in acute myeloid leukemia models. In some embodiments, inhibition of autophagy and anti-tumor activity by solid-state forms described herein are evaluated in syngeneic murine genetically engineered models (GEMs) of mutant RAS cancers. In some embodiments, inhibition of autophagy and antitumor activity by solid-state forms described herein are evaluated in the murine GEM syngeneic orthotopic pancreatic cancer model known as the KPC model (LSL-KrasG12D / +;LSL- Trp53R172II / +;Pdx- l-Cre) or variants of the KPC model.[000325] In some embodiments, solid-state forms described herein will be evaluated in xenograft or GEM cancer models in combination with a MEK inhibitor. In some embodiments, solid-state forms described herein will be evaluated in xenograft or GEM cancer models in combination with a RAF inhibitor. In some embodiments, solid-state forms described herein will be evaluated in xenograft or GEM cancer models in combination with an ERK inhibitor. In someembodiments, solid-state forms described herein will be evaluated in xenograft or GEM cancer models in combination with a RAS G12C direct inhibitor.[0003261 Insome embodiments, inhibition of autophagy and anti-tumor activity by solid- state forms described herein is evaluated in immunocompetent murine cancer models to assess an immunomodulatory component to the mechanism of action of ULK inhibitors. In some embodiments, the immunocompetent murine model is the murine GEM syngeneic orthotopic pancreatic cancer model known as the KPC model (LSL-KrasG12D +;LSL-Trp53R172H / +;Pdx-l- Cre) or variants of the KPC model. In some embodiments, immunomodulatory properties of solid-state forms described herein are evaluated in combination with a MEK inhibitor. In some embodiments, immunomodulatory properties of solid-state forms described herein are evaluated in combination with a RAF inhibitor. In some embodiments, immunomodulatory properties of solid-state forms described herein are evaluated in combination with an ERK inhibitor. In some embodiments, immunomodulatory properties of solid-state forms described herein are evaluated in combination with a RAS G12C direct inhibitor.[000327] In some embodiments, the immunomodulatory component of ULK inhibition is an enhanced innate immune response. In some embodiments, the immunomodulatory component of ULK inhibition is an enhanced adaptive immune response. In some embodiments, the immunomodulatory component of ULK inhibition is an enhanced activity of antigen-presenting cells. In some embodiments, the immunomodulatory component of ULK inhibition is an enhanced anti-tumor activity of myeloid cells including macrophages. In some embodiments, the immunomodulatory component of ULK inhibition is an enhanced anti-tumor activity of Natural Killer cells. In some embodiments, the immunomodulatory component of ULK inhibition is an enhanced activity of effector T Cells, including cytotoxic T Cells.[000328] In an embodiment, provided herein is a method of treating a disorder described herein that includes: administering a therapeutically effective amount of one or more solid-state forms described herein in a patient in need thereof, and during or after the course of administration (e.g., at discrete time points, such as one week, two weeks, or on month after initial administration of a contemplated solid-state form) detecting the engagement of the solid- state form with an ULK kinase, wherein detecting comprises contacting a sample obtained from the patient (including but not limited to a tumor, blood, saliva, or tissue) with a phospho-ATG13 antibody ELISA assay to detect inhibition of ULK kinase activity, e.g., based on the level ofphospho-ATG13 in the sample. Tn some embodiments, a contemplated method comprises optionally contacting a sample obtained from the patient (including but not limited to a tumor, blood, saliva, or tissue) prior to administration of the solid-state form with a phospho- ATG13 antibody ELISA assay, and comparing the level of phospho-ATG13 in the sample obtained prior to administration with the level of phospho-ATG13 in the sample obtained during or after the course of administration. In some embodiments, the phospho-ATG13 is p-S318ATG13.[000329] In an embodiment, provided herein is a method of treating a disorder described herein that includes: administering a therapeutically effective amount of one or more solid-state forms described herein in a patient in need thereof, and during or after the course of administration (e.g., at discrete time points, such as one week, two weeks, or on month after initial administration of a contemplated solid-state form) detecting the engagement of the solid- state form with an ULK kinase, wherein detecting comprises contacting a sample obtained from the patient (including but not limited to a tumor, blood, saliva, or tissue) with a phospho-ATG14 antibody ELISA assay to detect inhibition of ULK kinase activity, e.g., based on the level of phospho-ATG14 in the sample. In some embodiments, a contemplated method comprises optionally contacting a sample obtained from the patient (including but not limited to a tumor, blood, saliva, or tissue) prior to administration of the solid-state form with a phospho-ATG14 antibody ELISA assay, and comparing the level of phospho-ATG14 in the sample obtained prior to administration with the level of phospho-ATG14 in the sample obtained during or after the course of administration. In some embodiments, the phospho-ATG14 is p-ATG14 Ser29.[000330] In an embodiment, provided herein is a method of treating a disorder described herein that includes: administering a therapeutically effective amount of one or more solid-state forms described herein in a patient in need thereof, and during or after the course of administration (e.g., at discrete time points, such as one week, two weeks, or on month after initial administration of a contemplated solid-state form) detecting the engagement of the solid- state form with an ULK kinase, wherein detecting comprises contacting a sample obtained from the patient (including but not limited to a tumor, blood, saliva, or tissue) with a p62 antibody ELISA assay to detect inhibition of ULK kinase activity, e.g., based on the level of p62 in the sample. In some embodiments, a contemplated method comprises optionally contacting a sample obtained from the patient (including but not limited to a tumor, blood, saliva, or tissue) prior to administration of the solid-state form with a p62 antibody ELISA assay, and comparing the levelof p62 in the sample obtained prior to administration with the level of p62 in the sample obtained during or after the course of administration.[0003311 Inan embodiment, provided herein is a method of treating a disorder described herein that includes: administering a therapeutically effective amount of one or more solid-state forms described herein in a patient in need thereof, and during or after the course of administration (e.g., at discrete time points, such as one week, two weeks, or on month after initial administration of a contemplated solid-state form) detecting the engagement of the solid- state form with an ULK kinase, wherein detecting comprises contacting a sample obtained from the patient (including but not limited to a tumor, blood, saliva, or tissue) with a pBeclin antibody ELISA assay to detect inhibition of ULK kinase activity, e.g., based on the level of pBeclin in the sample. In some embodiments, a contemplated method comprises optionally contacting a sample obtained from the patient (including but not limited to a tumor, blood, saliva, or tissue) prior to administration of the solid-state form with a pBeclin antibody ELISA assay, and comparing the level of pBeclin in the sample obtained prior to administration with the level of pBeclin in the sample obtained during or after the course of administration.[000332] The solid-state forms provided herein may be administered to patients (animals and humans) in need of such treatment in dosages that will provide optimal pharmaceutical efficacy. It will be appreciated that the dose required for use in any particular application will vary from patient to patient, not only with the particular solid-state form or composition selected, but also with the route of administration, the nature of the condition being treated, the age and condition of the patient, concurrent medication or special diets then being followed by the patient, and other factors, with the appropriate dosage ultimately being at the discretion of the attendant physician. For treating clinical conditions and diseases noted above, a solid-state form provided herein may be administered orally, subcutaneously, topically, parenterally, by inhalation spray or rectally in dosage unit formulations containing conventional non-toxic pharmaceutically acceptable carriers, adjuvants and vehicles. Parenteral administration may include subcutaneous injections, intravenous or intramuscular injections or infusion techniques. [000333] Treatment can be continued for as long or as short a period as desired. The compositions may be administered on a regimen of, for example, one to four or more times per day. A suitable treatment period can be, for example, at least about one week, at least about twoweeks, at least about one month, at least about six months, at least about 1 year, or indefinitely. A treatment period can terminate when a desired result is achieved.[0003341 Insome embodiments, the method described herein comprises administering a therapeutically effective amount of the compound to the patient. In some embodiments, the method described herein comprises orally administering the compound to the patient. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1000 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 900 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 800 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 700 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 600 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the methoddescribed herein comprises administering to the patient about 20 mg to about 400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 90 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 80 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 70 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 60 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 50 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[0003351 Insome embodiments, the method described herein comprises administering to the patient about 50 mg to about 1500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 1400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 1300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 1200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the methoddescribed herein comprises administering to the patient about 50 mg to about 1100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 1000 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 900 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 800 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 700 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 600 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 90 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 80 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg toabout 70 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 60 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[000336] In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1000 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 900 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 800 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 700 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 600 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprisesadministering to the patient about 100 mg to about 400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[000337] In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1000 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 900 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 800 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 700 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 600 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. Insome embodiments, the method described herein comprises administering to the patient about 200 mg to about 500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. [000338] In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1000 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 900 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 800 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 700 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 600 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. Insome embodiments, the method described herein comprises administering to the patient about 300 mg to about 500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[000339] In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1000 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 900 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 800 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 700 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 600 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about400 mg to about 500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[0003401 Insome embodiments, the method described herein comprises administering to the patient about 20 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 30 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 40 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg, twice daily, of the solid- state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 60 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 70 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 80 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 90 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg, twice daily, of the solid- state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 110 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 120 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 130 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 140 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, themethod described herein comprises administering to the patient about 150 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 250 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 350 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 450 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 550 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 600 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 650 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 700 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 750 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 800 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method describedherein comprises administering to the patient about 850 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 900 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 950 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1000 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1050 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1150 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1250 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1350 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1450 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[000341] In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1500 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1400 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1300 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1200 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1100 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1000 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 900 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 800 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 700 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 600 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 500 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 400 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 300 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method describedherein comprises administering to the patient about 20 mg to about 200 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 100 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 90 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 80 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 70 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 60 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 50 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[000342] In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 1500 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 1400 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 1300 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 1200 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 1100 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 1000 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administeringto the patient about 50 mg to about 900 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 800 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 700 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 600 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 500 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 400 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 300 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 200 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 100 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 90 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 80 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 70 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 60 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[000343] In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1500 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1400 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1300 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1200 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1100 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1000 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 900 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 800 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 700 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 600 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 500 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 400 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 300 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In someembodiments, the method described herein comprises administering to the patient about 100 mg to about 200 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[000344] In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1500 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1400 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1300 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1200 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1100 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1000 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 900 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 800 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 700 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 600 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 500 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 400 mg, once daily, of the solid-state form of the compoundrepresented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 300 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[000345] In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1500 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1400 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1300 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1200 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1100 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1000 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 900 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 800 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 700 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 600 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 500 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administeringto the patient about 300 mg to about 400 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[0003461 Insome embodiments, the method described herein comprises administering to the patient about 400 mg to about 1500 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1400 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1300 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1200 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1100 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1000 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 900 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 800 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 700 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 600 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 500 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[000347] In some embodiments, the method described herein comprises administering to the patient about 20 mg, once daily, of the solid-state form of the compound represented byFormula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 30 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 40 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg, once daily, of the solid- state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 60 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 70 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 80 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 90 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg, once daily, of the solid- state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 110 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 120 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 130 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 140 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 150 mg, once daily, of the solid- state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvatethereof. Tn some embodiments, the method described herein comprises administering to the patient about 250 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 350 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg, once daily, of the solid- state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 450 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 500 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 550 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 600 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 650 mg, once daily, of the solid- state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 700 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 750 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 800 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 850 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 900 mg, once daily, of the solid- state form of the compound represented by Formula (I) or a solvate thereof. In someembodiments, the method described herein comprises administering to the patient about 950 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1000 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1050 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1100 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1150 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1200 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1250 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1300 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1350 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1400 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1450 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1500 mg, once daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[000348] The disclosure contemplates administration of the solid-state form of the compound represented by Formula (I), to a patient in need thereof prior (neo-adjuvant) or after (adjuvant) surgery (e.g., surgical treatment of cancer). In some embodiments, the solid-state form of the compound represented by Formula (I), is administered as an adjuvant. In someembodiments, the solid-state form of the compound represented by Formula (T), is administered as a neo-adjuvant. In some embodiments, the solid-state form of the compound represented by Formula (I), is administered as a neo-adjuvant and an adjuvant. In some embodiments, the solid- state form of the compound represented by Formula (I), is administered to a patient in need thereof as a neo-adjuvant for a period of 1 month to 6 months, followed by administration of the solid-state form of the compound represented by Formula (I), as an adjuvant for a period from 1 day to 100 years. In some embodiments, administration of the solid-state form of the compound represented by Formula (I), is administered to a patient in need thereof as a neo-adjuvant for a period of 1 month to 6 months, followed by administration of the solid-state form of the compound represented by Formula (I), as an adjuvant for a period from 1 day to 5 years. In some embodiments, administration of the solid-state form of the compound represented by Formula (I), is administered to a patient in need thereof as a neo-adjuvant for a period of 3 months to 6 months, followed by administration of the solid-state form of the compound represented by Formula (I), as an adjuvant for a period from 1 day to 5 years. In some embodiments, no administration of the solid-state form of the compound represented by Formula (I), occurs prior to surgery. In some embodiments, the solid-state form of the compound represented by Formula (I), is administered as an adjuvant for a period from 1 day to 100 years. In some embodiments, the solid-state form of the compound represented by Formula (I), is administered as an adjuvant for a period from 1 day to 5 years.Combination therapy[0003491 Solid-state salt forms described herein can be administered in combination with one or more additional therapeutic agents to treat a disorder described herein, such as a cancer described herein. For example, provided in the present disclosure is a pharmaceutical composition comprising a solid-state salt form described herein, one or more additional therapeutic agents, and a pharmaceutically acceptable excipient. In some embodiments, a solid- state salt form described herein and one additional therapeutic agent is administered. In some embodiments, a solid-state salt form described herein and two additional therapeutic agents are administered. In some embodiments, a solid-state salt form described herein and three additional therapeutic agents are administered.[000350] Combination therapy can be achieved by administering two or more therapeutic agents, each of which is formulated and administered separately. For example, a solid-state saltform described herein and an additional therapeutic agent can be formulated and administered separately. Combination therapy can also be achieved by administering two or more therapeutic agents in a single formulation, for example a pharmaceutical composition comprising a solid- state salt form described herein as one therapeutic agent and one or more additional therapeutic agents. For example, a solid-state salt form described herein and an additional therapeutic agent can be administered in a single formulation. Other combinations are also encompassed by combination therapy. While the two or more agents in the combination therapy can be administered simultaneously, they need not be. For example, administration of a first agent (or combination of agents) can precede administration of a second agent (or combination of agents) by minutes, hours, days, or weeks. Thus, the two or more agents can be administered within minutes of each other or within 1, 2, 3, 6, 9, 12, 15, 18, or 24 hours of each other or within 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14 days of each other or within 2, 3, 4, 5, 6, 7, 8, 9, or weeks of each other. In some cases even longer intervals are possible. While in many cases it is desirable that the two or more agents used in a combination therapy be present in within the patient's body at the same time, this need not be so.[000351] Combination therapy can also include two or more administrations of one or more of the agents used in the combination using different sequencing of the component agents. For example, if agent X and agent Y are used in a combination, one could administer them sequentially in any combination one or more times, e.g., in the order X-Y-X, X-X-Y, Y-X-Y, Y- Y-X, X-X-Y- Y, etc.[000352] Combination therapy can also include two or more administrations of one or more of the agents used in the combination using different routes of administration. Each of the one or more of the agents may be independently administered orally, subcutaneously, topically, parenterally, by inhalation spray or rectally in dosage unit formulations containing conventional non-toxic pharmaceutically acceptable carriers, adjuvants and vehicles. Parenteral administration may include subcutaneous injections, intravenous or intramuscular injections or infusion techniques.[000353] In some embodiments, the methods and uses described herein further comprise administering to the patient one or more additional therapeutic agents.[000354] In some embodiments, the one or more additional therapeutic agents is selected from the group consisting of a MAP kinase pathway inhibitor, an EGFR inhibitor, a KIT inhibitor, a FLT3 inhibitor, and combinations thereof.[000355] In some embodiments, the MAP kinase pathway inhibitor is selected from the group consisting of a MEK inhibitor, an ERK inhibitor, a RAF inhibitor, and a Ras inhibitor, and combinations thereof.[000356] Exemplary MEK inhibitors include but are not limited to trametinib, selumetinib, cobimetinib, binimetinib, avutometinib, mirdametinib, pimasertib, refametinib, and pelitinib, and pharmaceutically acceptable salts thereof.[000357] Exemplary ERK inhibitors include but are not limited to ulixertinib, SCH772984, LY3214996, ravoxertinib, VX-l le, ERAS-007, and ASTX-029, and pharmaceutically acceptable salts thereof.[000358] Exemplary RAF inhibitors include but are not limited to LY3009120, LXH254 (naporafenib), RAF709, KIN-2787 (exarafenib), dabrafenib, vemurafenib, VS-6766, encorafenib, tovorafenib, PLX8394, agerafenib, lifirafenib, belvarafenib, uplarafenib, JZP815, BDTX-4933, and DCC-3084, and pharmaceutically acceptable salts thereof.[000359] In some embodiments, the Ras inhibitor is a KRAS inhibitor, for example, a KRAS G12C inhibitor, a KRAS G12D inhibitor, or a pan -KRAS inhibitor.[000360] Exemplary Ras inhibitors include but are not limited to sotorasib (AMG-510), adagrasib (MRTX849), LY3537982, opnurasib, divarasib (GDC-6036), fulzerasib, MRTX-1133, JAB-21822, GFH925, ELI-002, RMC-6236, ASP3082, YL-17231, QTX3034, RMC-9805, HRS- 4642, RMC-8839, INCB161734, and RMC-6291, and pharmaceutically acceptable salts thereof.[000361] Exemplary EGFR inhibitors include but are not limited to cetuximab, osimertinib, gefitinib, lapatinib, erlotinib, dacomitinib, neratinib, and afatinib, and pharmaceutically acceptable salts thereof.[000362] Exemplary KIT inhibitors include but are not limited to ripretinib, avapritinib, sunitinib, AZD3229 (NB003), THE-630, imatinib, midostaurin, bezuclastinib, olverembatinib (HQP1351), famitinib, IDRX-42 (M4205), elenestinib, BLU-808, IDRX-73, SLRN-517, THB335, DCC-3009, pexidartinib, and regorafenib, and pharmaceutically acceptable salts thereof.[000363] Exemplary FLT3 inhibitors include, but are not limited to, midostaurin, lestaurtinib, ponatinib, tandutinib, quizartinib , crenolanib, and gilteritinib, and pharmaceutically acceptable salts thereof.[000364] In some embodiments, the additional therapeutic agent is a PI3K inhibitor. Exemplary PI3K inhibitors include, but are not limited to, alpelisib, LY294002, idelalisib, duvelisib, copanlisib, umbralisib, and omipalisib, and pharmaceutically acceptable salts thereof. [000365] In some embodiments, the additional therapeutic agent is an mTOR inhibitor. Exemplary mTOR inhibitors include, but are not limited to, rapamycin, everolimus, temsirolimus, PF04691502, and PP242, and pharmaceutically acceptable salts thereof.[000366] In some embodiments, the additional therapeutic agent is an AKT inhibitor. Exemplary AKT inhibitors include, but are not limited to, ipatasertib, and capivasertib, and pharmaceutically acceptable salts thereof.[000367] In some embodiments, the additional therapeutic agent is a RTK pathway inhibitor. Such RTK pathway inhibitors include, for example, PDGFRa inhibitors, VEGFR inhibitors, anti-VEGF therapeutics, BCR-Abl inhibitors, ALK inhibitors, and CSF-1R inhibitors.[000368] Exemplary PDGFRa inhibitors include, but are not limited to, ripretinib, JNJ10198409, crenolanib, and avapritinib, and pharmaceutically acceptable salts thereof.[000369] Exemplary VEGFR inhibitors include, but are not limited to, regorafenib, axitinib, lenvatinib, cabozantinib, sorafenib, sunitinib, vandetinib, nintedanib, tivozanib, and pazopanib, and pharmaceutically acceptable salts thereof. Exemplary anti-VEGF therapeutics include bevacizumab.[000370] Exemplary BCR-Abl inhibitors include, but are not limited to, imatinib, nilotinib, dasatinib, bosutinib, and ponatinib, and asciminib, and pharmaceutically acceptable salts thereof. [000371] Exemplary ALK inhibitors include, but are not limited to, loralatinib, brigatinib, ceritinib, crizotinib, and alectinib, and pharmaceutically acceptable salts thereof.[000372] Exemplary CSF-1R inhibitors include but are not limited to axatilimab, AMG820, IMC-CS4, cabiralizumab, lacnotuzumab, emactuzumab, PD-0360324, vimseltinib, pexidartinib, sotuletinib, GW2580, PLX7486, PLX5622, edicotinib, Ki20227, AZD7507, ARRY-382, BLZ945, JNJ-40346527, and pimicotinib, and pharmaceutically acceptable salts thereof.[000373] In some embodiments, the additional therapeutic agent is a Bcl-2 inhibitor. Exemplary Bcl-2 inhibitors include, but are not limited to venetoclax, navitoclax, obatoclax mesylate, palcitoclax, R-(-)-gossypol acetic acid, oblimersen sodium, LP-118, and sonrotoclax. [000374] The solid-state salt forms described herein may be administered in combination with other therapeutic agents known to treat cancers. Such other therapeutic agents include radiation therapy, anti -tubulin agents, DNA alkylating agents, DNA synthesis-inhibiting agents, DNA intercalating agents, anti-estrogen agents, anti -androgens, steroids, anti-EGFR agents, kinase inhibitors, mTOR inhibitors, PI3 kinase inhibitors, AKT inhibitors, cyclin-dependent kinase inhibitors, CD4 / CD6 kinase inhibitors, topoisomerase inhibitors, Histone Deacetylase (HD AC) inhibitors, DNA methylation inhibitors, anti-HER2 agents, anti -angiogenic agents, proteasome inhibitors, PARP inhibitors, cell cycle regulating kinase inhibitors, thalidomide, lenalidomide, antibody-drug-conjugates (ADCs), immunotherapeutic agents including immunomodulating agents, targeted therapeutic agents, cancer vaccines, and CAR-T cell therapy.[000375] In an embodiment, the additional therapeutic agents can be chemotherapeutic agents including but not limited to an anti-tubulin agents (for example, paclitaxel, paclitaxel protein-bound particles for injectable suspension including nab-paclitaxel, eribulin, docetaxel, ixabepilone, vincristine, auristatins, or maytansinoids), vinorelbine, DNA-alkylating agents (including cisplatin, carboplatin, oxaliplatin, cyclophosphamide, ifosfamide, temozolomide), DNA intercalating agents or DNA topoisomerase inhibitors (including anthracy clines such as doxorubicin, pegylated liposomal doxorubicin, daunorubicin, idarubicin, mitoxantrone, or epirubicin, camptothecins such as topotecan, irinotecan, or exatecan), 5 -fluorouracil, capecitabine, cytarabine, decitabine, 5-aza cytadine, gemcitabine and methotrexate.[000376] In some embodiments, the additional therapeutic agent is selected from the group consisting of anti-tubulin agents, vinorelbine, DNA-alkylating agents, DNA intercalating agents, 5-fluorouracil, capecitabine, cytarabine, decitabine, 5-azacytadine, gemcitabine, irinotecan, and methotrexate.[000377] In some embodiments, the additional therapeutic agents can be kinase inhibitors including but not limited to erlotinib, gefitinib, neratinib, afatinib, osimertinib, lapatanib, crizotinib, brigatinib, ceritinib, alectinib, lorlatinib, everolimus, temsirolimus, abemaciclib, LEE011, palbociclib, cabozantinib, sunitinib, pazopanib, sorafenib, regorafenib, sunitinib,axitinib, dasatinib, imatinib, ripretinib, avapritinib, JNJ10198409, nilotinib, idelalisib, ibrutinib, BLU-285, BLU-667, Loxo 292, larotrectinib, crenolanib, gilteritinib, and quizartinib, antiestrogen agents including but not limited to tamoxifen, fulvestrant, anastrozole, letrozole, and exemestane, anti-androgen agents including but not limited to abiraterone acetate, enzalutamide, nilutamide, bicalutamide, flutamide, cyproterone acetate, steroid agents including but not limited to prednisone and dexamethasone, PARP inhibitors including but not limited to neraparib, olaparib, talazoparib, and rucaparib, topoisomerase I inhibitors including but not limited to irinotecan, camptothecin, exatecan, and topotecan, topoisomerase II inhibitors including but not limited to anthracyclines, etoposide, etoposide phosphate, and mitoxantrone, Histone Deacetylase (HDAC) inhibitors including but not limited to vorinostat, romidepsin, panobinostat, valproic acid, and belinostat, DNA methylation inhibitors including but not limited to DZNep and 5-aza-2'-deoxy cytidine, proteasome inhibitors including but not limited to bortezomib and carfilzomib, thalidomide, lenalidomide, pomalidomide, biological agents including but not limited to trastuzumab, ado-trastuzumab, pertuzumab, cetuximab, panitumumab, ipilimumab, tremelimumab, anti-PD-1 agents including pembrolizumab, nivolumab, pidilizumab, and Cemiplimab, anti-PD-Ll agents including atezolizumab, avelumab, durvalumab and BMS- 936559, anti-angiogenic agents including bevacizumab and aflibercept, and antibody-drug- conjugates (ADCs) including DM1, DM4, MMAE, MMAF, or camptothecin payloads, brentuximab vedotin and trastuzumab emtansine, radiotherapy, therapeutic vaccines including but not limited to sipuleucel-T.[000378] In some embodiments, the additional therapeutic agents can be immunomodulatory agents including but not limited to anti-PD-1 or anti-PDL-1 therapeutics including pembrolizumab, nivolumab, atezolizumab, durvalumab, BMS-936559, avelumab, or dostarlimab, anti-TIM3 (anti-HAVcr2) therapeutics including but not limited to TSR-022 or MBG453, anti-LAG3 therapeutics including but not limited to relatlimab, LAG525, or TSR-033, anti-4-lBB (anti-CD37, anti-TNFRSF9), CD40 agonist therapeutics including but not limited to SGN-40, CP-870,893 or R07009789, anti-CD47 therapeutics including but not limited to Hu5F9-G4, anti-CD20 therapeutics, anti-CD38 therapeutics, STING agonists including but not limited to ADU-S100, MK-1454, ASA404, or amidobenzimidazoles, anthracyclines including but not limited to doxorubicin or mitoxanthrone, hypomethylating agents including but not limited to azacytidine or decitabine, other immunomodulatory therapeutics including but notlimited to epidermal growth factor inhibitors, statins, metformin, angiotensin receptor blockers, thalidomide, lenalidomide, pomalidomide, prednisone, or dexamethasone.[0003791 Insome embodiments, the additional therapeutic agent is an immunomodulatory agent. In some embodiments, the immunomodulatory agent is selected from the group consisting of pembrolizumab, nivolumab, atezolizumab, durvalumab, BMS-936559, avelumab, cetuximab, TSR-022, MBG453, relatlimab, LAG525, TSR-033, SGN-40, CP-870,893, R07009789, Hu5F9- G4, ADU-S100, MK-1454, ASA404, doxorubicin, mitoxanthrone, azacytidine, decitabine, statins, metformin, thalidomide, lenalidomide, pomalidomide, prednisone, dexamethasone, and dostarlimab, and pharmaceutically acceptable salts thereof.[000380] In some embodiments, the additional therapeutic agent is selected from a luteinizing hormone-releasing hormone (LHRH) analog, including goserelin and leuprolide. [000381] In some embodiments, the additional therapeutic agent is selected from the group consisting of selected from the group consisting of everolimus, trabectedin, abraxane, TLK 286, AV-299, DN-101, pazopanib, GSK690693, RTA 744, ON O91O.Na, AZD 6244 (ARRY- 142886), AMN-107, TKI-258, GSK461364, AZD 1152, enzastaurin, vandetanib, ARQ-197, MK-0457, MLN8054, PHA-739358, R-763, AT-9263, pemetrexed, erlotinib, dasatanib, nilotinib, decatanib, panitumumab, amrubicin, oregovomab, Lep-etu, nolatrexed, azd2171, batabulin, of atumtunab, zanolimumab, edotecarin, tetrandrine, rubitecan, tesmilifene, oblimersen, ticilimumab, ipilimumab, gossypol, Bio 111, 131-I-TM-601, ALT-110, BIO 140, CC 8490, cilengitide, gimatecan, IL13-PE38QQR, INO 1001, IPdRi KRX-0402, lucanthone, LY 317615, neuradiab, vitespan, Rta 744, Sdx 102, talampanel, atrasentan, Xr 311, romidepsin, ADS-100380, sunitinib, 5 -fluorouracil, vorinostat, etoposide, gemcitabine, doxorubicin, irinotecan, liposomal doxorubicin, 5'-deoxy-5-fluorouridine, vincristine, temozolomide, ZK- 304709, seliciclib; PD0325901, AZD-6244, capecitabine, L-Glutamic acid, N-[4-[2-(2-amino- 4,7-dihydro-4-oxo-lH-pyrrolo[2,3-d]pyrimidin-5-yl)- ethyl]benzoyl]-, disodium salt, heptahydrate, camptothecin, PEG-labeled irinotecan, tamoxifen, toremifene citrate, anastrazole, exemestane, letrozole, DES(diethylstilbestrol), estradiol, estrogen, conjugated estrogen, bevacizumab, IMC-1C11, CHIR-258,); 3-[5-(methylsulfonylpiperadinemethyl)-indolylj- quinolone, vatalanib, AG-013736, AVE-0005, goserelin acetate, leuprolide acetate, triptorelin pamoate, medroxyprogesterone acetate, hydroxyprogesterone caproate, megestrol acetate, raloxifene, bicalutamide, flutanide, nilutamide, megestrol acetate, CP-724714; TAK-165, HKI-272, erlotinib, lapatanib, canertinib, ABX-EGF antibody, erbitux, EKB-569, PKI-166, GW- 572016, lonafarnib, BMS-214662, tipifarnib; amifostine, NVP-LAQ824, suberoyl analide hydroxamic acid, valproic acid, trichostatin A, FK-228, SU11248, sorafenib, KRN951, aminoglutethimide, arnsacrine, anagrelide, L-asparaginase, Bacillus Calmette-Guerin (BCG) vaccine, bleomycin, buserelin, busulfan, carboplatin, carmustine, chlorambucil, cisplatin, cladribine, clodronate, cyproterone, cytarabine, dacarbazine, dactinomycin, daunorubicin, diethylstilbestrol, epirubicin, fludarabine, fludrocortisone, fluoxymesterone, flutamide, gemcitabine, gleevac, hydroxyurea, idarubicin, ifosfamide, imatinib, leuprolide, levamisole, lomustine, mechlorethamine, melphalan, 6-mercaptopurine, mesna, methotrexate, mitomycin, mitotane, mitoxantrone, nilutamide, octreotide, oxaliplatin, pamidronate, pentostatin, plicamycin, porfimer, procarbazine, raltitrexed, rituximab, streptozocin, teniposide, testosterone, thalidomide, thioguanine, thiotepa, tretinoin, vindesine, 13-cis-retinoic acid, phenylalanine mustard, uracil mustard, estramustine, altretamine, floxuridine, 5-deooxyuridine, cytosine arabinoside, 6- mecaptopurine, deoxycoformycin, calcitriol, valrubicin, mithramycin, vinblastine, vinorelbine, topotecan, razoxin, marimastat, COL-3, neovastat, BMS-275291, squalamine, endostatin, SU5416, SU6668, EMD121974, interleukin- 12, IM862, angiostatin, vitaxin, droloxifene, idoxyfene, spironolactone, finasteride, cimitidine, trastuzumab, denileukin diftitox, gefitinib, bortezimib, irinotecan, topotecan, doxorubicin, docetaxel, vinorelbine, bevacizumab (monoclonal antibody) and erbitux, cremophor-free paclitaxel, epithilone B, BMS-247550, BMS-310705, droloxifene, 4-hydroxytamoxifen, pipendoxifene, ERA-923, arzoxifene, fulvestrant, acolbifene, lasofoxifene, idoxifene, TSE-424, HMR-3339, ZK186619, PTK787 / ZK 222584, VX-745, PD 184352, rapamycin, 40-O-(2-hydroxyethyl)-rapamycin, temsirolimus, AP- 23573, RAD001, ABT-578, BC-210, LY294002, LY292223, LY292696, LY293684, LY293646, wortmannin, ZM336372, L-779,450, PEG-filgrastim, darbepoetin, erythropoietin, granulocyte colony-stimulating factor, zolendronate, prednisone, cetuximab, granulocyte macrophage colony-stimulating factor, histrelin, pegylated interferon alfa-2a, interferon alfa-2a, pegylated interferon alfa-2b, interferon alfa-2b, azacitidine, PEG-L-asparaginase, lenalidomide, gemtuzumab, hydrocortisone, interleukin-11, dexrazoxane, alemtuzumab, all-transretinoic acid, ketoconazole, interleukin-2, megestrol, immune globulin, nitrogen mustard, methylprednisolone, ibritgumomab tiuxetan, androgens, decitabine, hexamethylmelamine, bexarotene, tositumomab, arsenic trioxide, cortisone, editronate, mitotane, cyclosporine, liposomal daunorubicin, Edwina-asparaginase, strontium 89, casopitant, netupitant, an NK-1 receptor antagonists, palonosetron, aprepitant, diphenhydramine, hydroxyzine, metoclopramide, lorazepam, alprazolam, haloperidol, droperidol, dronabinol, dexamethasone, methylprednisolone, prochlorperazine, granisetron, ondansetron, dolasetron, tropisetron, pegfilgrastim, erythropoietin, epoetin alfa and darbepoetin alfa, ipilumumab, vemurafenib, MRTX849, MRTX1133, AMG510, GDC-6036, RMC-9805, RMC-6291, RMC-6236, belvarafenib, KIN-2787, ERAS-007, ASTX-029, and mixtures thereof [000382] In some embodiments, the additional therapeutic agent is a chemotherapeutic agent. Exemplary chemotherapeutic agents include but are not limited to anti-tubulin agents, vinorelbine, DNA-alkylating agents, DNA intercalating agents, 5-fluorouracil, capecitabine, cytarabine, decitabine, 5 -aza cytadine, gemcitabine, and methotrexate.Combination With One or More Additional Therapeutic Agents[000383] Described herein, in an embodiment, is a method of treating cancer in a patient in need thereof, comprising: (i) administering to the patient a therapeutically effective amount of the solid-state form of the compound represented by Formula (I) or a solvate thereof; and (ii) administering to the patient a therapeutically effective amount of one or more additional therapeutic agents. In some embodiments, the method described herein comprises orally administering the compound to the patient. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1500 mg, twice daily, of the solid- state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 1000 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the methoddescribed herein comprises administering to the patient about 20 mg to about 900 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 800 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 700 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 600 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 90 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 80 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 70 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg to about 60 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 20 mg toabout 50 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[0003841 Insome embodiments, the method described herein comprises administering to the patient about 50 mg to about 1500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 1400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 1300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 1200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 1100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 1000 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 900 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 800 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 700 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 600 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprisesadministering to the patient about 50 mg to about 300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 90 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 80 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 70 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg to about 60 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[000385] In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 1000 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method describedherein comprises administering to the patient about 100 mg to about 900 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 800 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 700 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 600 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 100 mg to about 200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[000386] In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvatethereof. Tn some embodiments, the method described herein comprises administering to the patient about 200 mg to about 1000 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 900 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 800 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 700 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 600 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg to about 300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. [000387] In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvatethereof. Tn some embodiments, the method described herein comprises administering to the patient about 300 mg to about 1000 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 900 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 800 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 700 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 600 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg to about 400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[000388] In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 1000 mg, twice daily, of the solid-state form of the compoundrepresented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 900 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 800 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 700 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 600 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg to about 500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof.[000389] In some embodiments, the method described herein comprises administering to the patient about 20 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 30 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 40 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 50 mg, twice daily, of the solid- state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 60 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 70 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 80 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 90 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the methoddescribed herein comprises administering to the patient about 100 mg, twice daily, of the solid- state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 110 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 120 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 130 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 140 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 150 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 200 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 250 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 300 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 350 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 400 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 450 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 500 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 550 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method describedherein comprises administering to the patient about 600 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 650 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 700 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 750 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 800 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 850 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 900 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 950 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1000 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1050 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1100 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1150 mg, twice daily, of the solid-state form of the compound represented by Formula (I) or a solvate thereof. In some embodiments, the method described herein comprises administering to the patient about 1200 mg,...

Claims

CLAIMSWe claim:

1. A solid-state form of the compound represented by Formula (I):solvates thereof.

2. An amorphous solid-state form of the compound represented by Formula (I):solvates thereof.

3. The amorphous solid-state form of the compound of claim 2, having an X-ray powder diffraction (XRPD) pattern substantially as shown in FIG. 14B.

4. A process for preparing the amorphous solid-state form of claim 2 or 3, comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) warming the mixture of the compound represented by Formula (I) and a solvent to provide a clear solution;(iii) cooling the resulting solution;(iv) lyophilizing the resulting solution to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the amorphous form.

5. The process of claim 4, wherein the solvent in step (i) is 1,4-dioxane.

6. The process of claim 4 or 5, wherein the warming in step (ii) is to about 40 °C.

7. An amorphous solid-state form of the compound represented by Formula (I) produced by the process of any one of claims 4-6.

8. The amorphous solid-state form of the compound of any one of claims 2-3 and 7, which is substantially pure.

9. The amorphous solid-state form of the compound of claim 8, which has a chemical purity of greater than 90% by weight.

10. The amorphous solid-state form of the compound of claim 8 or 9, which has a chemical purity of greater than 95% by weight.

11. The amorphous solid-state form of the compound of any one of claims 8-10, which has a chemical purity of greater than 97% by weight.

12. The amorphous solid-state form of the compound of any one of claims 8-11, which has a chemical purity of greater than 99% by weight.

13. The amorphous solid-state form of any one of claims 2-3 and 7-12, having not more than about 5 mol%, not more than about 3 mol%, or not more than about 1 mol% of other solid-state forms of the compound represented by Formula (I).

14. The amorphous solid-state form of any one of claims 2-3 and 7-13, which is essentially free of solvents.

15. A crystalline solid-state form of the compound represented by Formula (I):

16. The crystalline solid-state form of the compound of claim 15, which is crystalline solid- state Form 1, having an XRPD pattern comprising peaks, in terms of 2-theta, at about 6.68°, about 19.36°, and about 21.89°.

17. The crystalline solid-state form of the compound of claim 15 or 16, which is crystalline solid-state Form 1, having an XRPD pattern comprising peaks, in terms of 2-theta, at about 6.68°, about 12.82°, about 17.22°, about 19.36°, and about 21.89°.

18. The crystalline solid-state form of the compound of any one of claims 15-17, which is crystalline solid-state Form 1, having an XRPD pattern comprising peaks, in terms of 2-theta, at about 6.68°, about 12.82°, about 16.48°, about 17.22°, about 17.80°, about 19.36, and about 21.89°.

19. The crystalline solid-state form of the compound of any one of claims 15-18, which is crystalline solid-state Form 1, having an XRPD pattern substantially as shown in FIG. 1.

20. The crystalline solid-state form of the compound of any one of claims 15-19, which is crystalline solid-state Form 1, having a differential scanning calorimetry (DSC) thermogram comprising an endothermic peak at about 137 °C.

21. The crystalline solid-state form of the compound of any one of claims 15-20, which is crystalline solid-state Form 1, having a DSC thermogram substantially as shown in FIG. 3.

22. The crystalline solid-state form of the compound of any one of claims 15-21, which is crystalline solid-state Form 1, having a thermogravimetric / differential scanning calorimetry (TG / DSC) thermogram substantially as shown in FIG. 2.

23. The crystalline solid-state form of the compound of any one of claims 15-22, which is crystalline solid-state Form 1, having a 'H nuclear magnetic resonance (NMR) spectrum substantially as shown in FIG. 10.

24. A process for preparing the crystalline solid-state form of any one of claims 15-23, comprising:(i) providing a mixture of a compound represented by Formula (I) and a solvent;(ii) warming the mixture of the compound represented by Formula (I) and a solvent to provide a clear solution;(iii) cooling the resulting solution;(iv) evaporating the resulting solution to result in a solid precipitate; and(v) isolating the solid precipitate to obtain the crystalline solid-state form.

25. The process of claim 24, wherein the solvent in step (i) is selected from the group consisting of 1 -butanol, 1,2-di chloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2- methyltetrahydrofuran, 2-propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, N,N’- dimethylformamide, dioxane, 80:20 methanol -water, methyl isobutyl ketone and dichloromethane.

26. The process of claim 24 or 25, wherein the solvent in step (i) is selected from the group consisting of 1 -butanol, 1,2-dichloroethene, methyl ethyl ketone, 2-ethoxyethanol, 2- methyltetrahydrofuran, 2-propanol, ethanol, ethyl acetate, heptane, isopropyl acetate, and N,N’- dimethylformamide.

27. The process of any one of claims 24-26, wherein the warming in step (ii) is to about 40 °C.

28. A crystalline solid-state form of the compound represented by Formula (I) produced by the process of any one of claims 24-27.

29. The crystalline solid-state form of the compound of any one of claims 15-23 and 28, which is substantially pure.

30. The crystalline solid-state form of the compound of claim 29, which has a chemical purity of greater than 90% by weight.

31. The crystalline solid-state form of the compound of claim 29 or 30, which has a chemical purity of greater than 95% by weight.

32. The crystalline solid-state form of the compound of any one of claims 29-31, which has a chemical purity of greater than 97% by weight.

33. The crystalline solid-state form of the compound of any one of claims 29-32, which has a chemical purity of greater than 99% by weight.

34. The crystalline solid-state form of any one of claims 15-23 and 28-33, having not more than about 5 mol%, not more than about 3 mol%, or not more than about 1 mol% of other solid- state forms of the compound represented by Formula (I).

35. The crystalline solid-state form of any one of claims 15-23 and 28-34, which is essentially free of solvents.

36. A pharmaceutical composition comprising the solid-state form of any one of claims 1-3, 7-23, and 28-35, or a combination thereof, and a pharmaceutically acceptable excipient or carrier.

37. The pharmaceutical composition of claim 36, wherein the solid-state form is present in the composition in an amount of at least about 90% by weight.

38. The pharmaceutical composition of claim 36, comprising the crystalline solid-state form of the compound represented by Formula (I) of any one of claims 15-23, and 28-35 and theamorphous solid-state form of the compound represented by Formula (I) of any one of claims 2- 3, and 7-14.

39. A pharmaceutical composition consisting essentially of the solid-state form of any one of claims 1-3, 7-23, and 28-35, or a combination thereof, and a pharmaceutically acceptable excipient or carrier.

40. A method of treating a disease or disorder in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of the solid-state form of the compound of any one of claims 1-3, 7-23, and 28-35, or of the pharmaceutical composition of any one of claims 36-39 .

41. The method of claim 40, wherein the disease or disorder is cancer.

42. The method of claim 41, wherein the cancer is selected from the group consisting of gastrointestinal stromal tumors, esophageal cancer, gastric cancer, melanomas, gliomas, glioblastomas, gynecological cancers, bladder cancer, pancreatic cancer, prostate cancer, lung cancers, breast cancers, renal cancers, hepatic cancers, osteosarcomas, Ewing sarcoma, multiple myelomas, cervical carcinomas, cancers that are metastatic to bone, papillary thyroid carcinoma, colorectal cancer, acute myeloid leukemia, relapsed acute myeloid leukemia, refractory acute myeloid leukemia, myelodysplastic syndrome, acute lymphocytic leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia, myeloproliferative neoplasms, and mantle cell lymphoma.

43. The method of any one of claims 40-42, further comprising administering to the patient one or more additional therapeutic agents.

44. The method of claim 43, wherein the one or more additional therapeutic agents is selected from the group consisting of a MAP kinase pathway inhibitor, an EGFR inhibitor, a KIT inhibitor, a FLT3 inhibitor, and combinations thereof.

45. The method of claim 44, wherein the MAP kinase pathway inhibitor is selected from the group consisting of a MEK inhibitor, an ERK inhibitor, a RAF inhibitor, and a Ras inhibitor, and combinations thereof.

46. The method of claim 45, wherein the MEK inhibitor is selected from the group consisting of trametinib, selumetinib, cobimetinib, binimetinib, avutometinib, mirdametinib, pimasertib, refametinib, and pelitinib, and pharmaceutically acceptable salts thereof.

47. The method of claim 45, wherein the ERK inhibitor is selected from the group consisting of ulixertinib, SCH772984, LY3214996, ravoxertinib, and VX-1 le, and pharmaceutically acceptable salts thereof.

48. The method of claim 45, wherein the RAF inhibitor is selected from the group consisting of LY3009120, LXH254 (naporafenib), RAF709, KIN-2787 (exarafenib), dabrafenib, vemurafenib, encorafenib, tovorafenib, PLX8394, agerafenib, lifirafenib, belvarafenib, uplarafenib, JZP815, BDTX-4933, and DCC-3084, and pharmaceutically acceptable salts thereof.

49. The method of claim 45, wherein the Ras inhibitor is selected from the group consisting of sotorasib (AMG-510), adagrasib (MRTX849), LY3537982, opnurasib, divarasib, fulzerasib, MRTX-1133, JAB-21822, GFH925, ELI-002, RMC-6236, ASP3082, YL-17231, QTX3034, RMC-9805, HRS-4642, RMC-8839, INCB161734, and RMC-6291, and pharmaceutically acceptable salts thereof.

50. The method of claim 44, wherein the EGFR inhibitor is selected from the group consisting of cetuximab, osimertinib, gefitinib, lapatinib, erlotinib, dacomitinib, neratinib, and afatinib, and pharmaceutically acceptable salts thereof.

51. The method of claim 44, wherein the KIT inhibitor is selected from the group consisting of ripretinib, avapritinib, sunitinib, AZD3229 (NB003), THE-630, imatinib, midostaurin, bezuclastinib, olverembatinib (HQP1351), famitinib, IDRX-42 (M4205), elenestinib, BLU-808, IDRX-73, SLRN-517, THB335, DCC-3009, pexidartinib, and regorafenib, and pharmaceutically acceptable salts thereof.

52. The method of claim 44, wherein the FLT3 inhibitor is selected from the group consisting of midostaurin, lestaurtinib, ponatinib, tandutinib, quizartinib , and gilteritinib, and pharmaceutically acceptable salts thereof.

53. The method of claim 43, wherein the additional therapeutic agent is a chemotherapeutic agent.

54. The method of claim 53, wherein the chemotherapeutic agent is a selected from the group consisting of anti-tubulin agents, vinorelbine, DNA-alkylating agents, DNA intercalating agents, 5-fluorouracil, capecitabine, cytarabine, decitabine, 5-aza cytadine, gemcitabine, and methotrexate.

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